Advisory Committees

Tykerb/Herceptin Combination Will Go Before FDA Advisory Panel

Wed, 30 May 2012 00:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee will review a combination of GlaxoSmithKline’s Tykerb (lapatinib) with Roche’s Herceptin (trastuzumab) that would offer patients with HER-2 positive metastatic breast cancer a chemo-free option.

Cancer Imaging In Clear Cell Renal Carcinoma Gets ODAC Attention As Pipeline Fills

Wed, 30 May 2012 00:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee will examine the extent (if any) to which the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information. ASCO abstracts show considerable research interest in the area.

Xarelto Review Sparks Debate Over Feasibility Of A Three-Drug ACS Regimen

Mon, 28 May 2012 00:00:00 -0400

While the focus of the Cardiovascular and Renal Drugs Advisory Committee’s meeting was on rivaroxaban’s use in treating acute coronary syndromes, some panelists questioned the wisdom of adding an antithrombin to current dual-antiplatelet therapy standard of care. The lack of data on rivaroxaban’s use with the two newest antiplatelet agents, prasugrel and ticagrelor, also could prove problematic from a labeling perspective due to theoretical concerns about increased bleeding.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 28 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says

Mon, 28 May 2012 00:00:00 -0400

Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.

Cancer Imaging In Clear Cell Renal Carcinoma Gets ODAC Attention As Pipeline Fills

Fri, 25 May 2012 00:00:00 -0400

Pfizer’s Vyndaqel Splits Advisory Committee; Now It Must Move FDA

Thu, 24 May 2012 00:00:00 -0400

In mirror-image votes, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee says that there is substantial evidence for surrogate endpoints but not for clinical endpoints for the drug to treat familial amyloid polyneuropathy.

ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says

Wed, 23 May 2012 00:00:00 -0400

Pfizer Vyndaqel Advisory Committee Pits Orphan Flexibility Vs. Data Shortcomings

Wed, 23 May 2012 00:00:00 -0400

FDA finds much to question in a single pivotal trial of Pfizer’s orphan drug Vyndaqel (tafamidis meglumine) for familial amyloid polyneuropathy, but the ultra-orphan nature of the disease may outweigh those concerns.

Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

Tue, 22 May 2012 00:00:00 -0400

FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.

OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes

Mon, 21 May 2012 00:00:00 -0400

FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users.

New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting

Mon, 21 May 2012 00:00:00 -0400

The Medicare Evidence Development & Coverage Advisory Committee was charged May 16 with helping CMS better define the evidence threshold under which the agency should or should not pursue a coverage- with-evidence-development policy.

Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP

Mon, 21 May 2012 00:00:00 -0400

FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.

Medicare CED Could Support, Benefit From Surveillance Systems Like FDA’s Sentinel – McClellan

Mon, 21 May 2012 00:00:00 -0400

At a May 16 Medicare Evidence Development and Coverage Advisory Committee meeting, former CMS and FDA Chief Mark McClellan advocated salvaging Medicare’s little-used coverage with evidence development policy for medical products.

“Next Phase” For CED Should Focus On Treatments That Lower Cost, MEDCAC Told

Mon, 21 May 2012 00:00:00 -0400

The next iteration of CMS’ Medicare coverage with evidence development policy should limit application of the reimbursement tool to treatments that can lower overall health care spending, Center for Medical Technology Policy CEO Sean Tunis told the Medicare advisory committee.

Recent Round Of Obesity Reviews Suggests CV Safety Standards Have Come Into Focus

Mon, 21 May 2012 00:00:00 -0400

The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 21 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Advisory Panel Endorses OraSure In-Home HIV Test

Mon, 21 May 2012 00:00:00 -0400

An FDA advisory committee endorses OraSure’s OraQuick in-home HIV test in a unanimous vote. If approved, OraQuick would be the first OTC test for HIV that untrained users can perform entirely in the home.

OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes

Mon, 21 May 2012 00:00:00 -0400

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

Tue, 15 May 2012 00:00:00 -0400

Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.

Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients

Mon, 14 May 2012 00:00:00 -0400

The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals.

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

Mon, 14 May 2012 00:00:00 -0400

Will Pharmacovigilance Be Enough To Address Questions About Pfizer’s Tofacitinib?

Mon, 14 May 2012 00:00:00 -0400

Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 14 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Another Arcalyst Trial May Be Regeneron’s Best Path To Approval In Gout

Mon, 14 May 2012 00:00:00 -0400

Recommending against approval, FDA’s Arthritis Advisory Committee says there is not enough data for Regeneron’s gout therapy and suggests that chronic and refractory populations should be studied.

Truvada PrEP REMS Needs More Work, FDA Panel Says

Mon, 14 May 2012 00:00:00 -0400

In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug.

Truvada PrEP REMS Needs More Work, FDA Panel Says

Mon, 14 May 2012 00:00:00 -0400

Weighty Issues: GW Obesity Outcomes Project Tests Model For Patient Input In Drug Development

Mon, 14 May 2012 00:00:00 -0400

A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards.

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

Fri, 11 May 2012 00:00:00 -0400

Renal Safety In The Spotlight At FDA Panel Review Of Gilead’s Quad

Fri, 11 May 2012 00:00:00 -0400

The four-drug, single-tablet HIV treatment regimen was associated with higher rates of serious adverse events and study drug discontinuations due to renal events in the pivotal trials. FDA is seeking the Antiviral Drugs Advisory Committee’s views on renal safety and whether monitoring recommendations should be stricter than those proposed by Gilead.

Lorcaserin Safety Questions Can Be Answered In Post-Market Study, Panel Tells FDA

Fri, 11 May 2012 00:00:00 -0400

FDA’s Endocrinologic and Metabolic Advisory Committee backs approval of Arena’s weight-loss drug 18 to 4 with one abstention. Uncertainty over the risk for heart disease remains a prime concern for panel members.

Truvada PrEP REMS Needs More Work, FDA Panel Says

Fri, 11 May 2012 00:00:00 -0400

Medicare CED’s Possible Link With Expedited Drug Approvals Could Arise At MedCAC Review

Thu, 10 May 2012 00:00:00 -0400

At its next meeting May 16, the Medicare Evidence Development and Coverage Advisory Committee will hear from former CMS and FDA head Mark McClellan, who has supported the notion of linking Medicare’s coverage with evidence development tool with accelerated drug approvals.

Panel Backs Pfizer’s Tofacitinib For RA, With Narrower Indication

Thu, 10 May 2012 00:00:00 -0400

FDA’s Arthritis Advisory Committee said May 9 that Pfizer had worded the second-line indication too broadly, and indicated that a 5 mg dose is to be preferred, at least to begin with, due to safety concerns.

Renal Safety In The Spotlight At FDA Panel Review Of Gilead’s Quad

Wed, 09 May 2012 00:00:00 -0400

Lorcaserin Advisory Committee Will Again Be Weighed Down By Safety Concerns

Tue, 08 May 2012 00:00:00 -0400

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will revisit Arena’s obesity drug May 10; readjudication finds fewer cancers in rats than previously identified, but new data fails to rule out the 50% increased risk for valvulopathy sought by FDA.

Regeneron Receives Resounding “No” From Advisory Committee On Arcalyst Approval In Gout

Tue, 08 May 2012 00:00:00 -0400

FDA’s Arthritis Advisory Committee votes 11-0 against approval of the interleukin-1 blocker for prevention of gout flares during uric-acid lowering therapy, saying the wrong population was studied and more data is needed.

Truvada Pre-Exposure Prophylaxis Data Have FDA Looking Ahead To REMS

Tue, 08 May 2012 00:00:00 -0400

Seemingly comfortable with the clinical data supporting a PrEP indication for the emtricitabine/tenofovir combination, FDA will ask its Antiviral Drugs Advisory Committee for input on Gilead’s proposed REMS, which does not include prescribing restrictions. FDA will ask the May 10 panel to vote whether the risk/benefit profile is acceptable in various subgroups.

AIDS Organizations Battle Over Truvada Prophylaxis Indication

Tue, 08 May 2012 00:00:00 -0400

Provocative ad campaign against approval of Truvada for pre-exposure prophylaxis pits the AIDS Healthcare Foundation against a coalition of 14 AIDS advocacy groups which are running a pro-Truvada ad in a handful of alternative papers; both sides will speak at the FDA’s advisory committee reviewing Gilead’s application to expand the product’s indication.

Pre-Submission Communication Issues May Hurt Regeneron’s Arcalyst In Gout

Tue, 08 May 2012 00:00:00 -0400

FDA warned in pre-submission meetings that the company’s safety database may not be adequate and those questions remain as the application goes to the Arthritis Advisory Committee.

Pfizer Tofacitinib’s Fate May Rest On Radiographic Data

Mon, 07 May 2012 00:00:00 -0400

The marketability and even the approvability of the first-in-class JAK inhibitor for treatment of rheumatoid arthritis may hinge on whether it can be shown to offer patients a structural benefit. FDA briefing documents for the May 9 advisory committee review show issues with those findings.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 07 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Pre-Submission Communication Issues May Hurt Regeneron’s Arcalyst In Gout

Fri, 04 May 2012 00:00:00 -0400

FDA warned in pre-submission meetings that the company’s safety database may not be adequate and those questions remain as the application goes to the Arthritis Advisory Committee.

2012 FDA Advisory Committee Recommendations

Tue, 01 May 2012 00:00:00 -0400

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

Weighty Issues: GW Obesity Drug Outcomes Project Tests a Model for Patient Input in Drug Development

Tue, 01 May 2012 00:00:00 -0400

FDA Actions, In Brief

Mon, 30 Apr 2012 00:00:00 -0400

FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 30 Apr 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA Opts For Full, Rather Than Accelerated, Approval Of GSK’s Votrient In Sarcoma

Fri, 27 Apr 2012 00:00:00 -0400

Despite advisory committee discussion about a possible accelerated approval for pazopanib with a confirmatory study to assess symptom benefit, the agency opted to grant regular approval, as had been requested by GlaxoSmithKline.

Senate User Fee Bill Heads To Mark-up Without Track-And-Trace

Tue, 24 Apr 2012 00:00:00 -0400

Manager’s amendment released in lead-up to committee mark-up still does not include drug tracking provisions, but will expand advisory committee recruiting and eliminate conflict of interest waivers using language in Rep. Burgess’ bill.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 23 Apr 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

India’s DCGI Said Replaced By Nation’s New Drug Advisory Committee

Thu, 19 Apr 2012 00:00:00 -0400

The Drug Controller General of India has been supplanted by the health ministry’s New Drug Advisory Committee in the area of drug approvals.

Questions About Clinical Effect Highlight Advisory Committee Uncertainty Over Astellas’ Mirabegron

Mon, 16 Apr 2012 00:00:00 -0400

Reproductive health drugs advisory committee gives FDA a recommendation for approval for treatment of overactive bladder, but few answers to safety questions, and raises concerns about efficacy.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 16 Apr 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Xarelto Expanded Indication May Depend On Containing Worries About Bleeding

Wed, 11 Apr 2012 00:00:00 -0400

FDA advisory committee will review J&J/Bayer’s anticoagulant for a claim of reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. The product has a profoundly stronger database, but the same set of safety concerns, compared to when it was initially approved.

Gardasil Getting Pediatric Safety Review

Mon, 09 Apr 2012 00:00:00 -0400

Despite the political noise around the human papillomavirus vaccine, there do not seem to be major new pediatric safety concerns for the Pediatric Advisory Committee to discuss as it reviews Gardasil and 14 other products.

Chelsea’s Northera: The Perils of Drawing Conclusions in Real Time

Mon, 09 Apr 2012 00:00:00 -0400

Despite a “yes” vote from an advisory committee, FDA sent Chelsea’s Northera back to the development phase with a complete response letter asking for data from another trial. There may have been nothing Chelsea could have done to get a better result—but the company could have held off on a post-panel victory lap.

Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs

Mon, 09 Apr 2012 00:00:00 -0400

Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 09 Apr 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Advisory Committee Recommends Mirabegron, But With Reservations About Efficacy And Safety

Mon, 09 Apr 2012 00:00:00 -0400

Reproductive Health Drugs Advisory Committee says Astellas’ overactive bladder drug met the endpoints of its special protocol assessment, but still has concerns about the drug’s clinical benefit and potential cardiovascular issues.

Anthrax MedKit Initiative Could Learn From OTC Studies – NDAC

Mon, 09 Apr 2012 00:00:00 -0400

FDA’s Nonprescription Drugs Advisory Committee recommends the HHS sponsors of an antibiotic MedKit take lessons from OTC drug development. But many advisory panel members at an April 2 meeting did not see clear benefits of allowing home stockpiling of doxycycline to treat anthrax.

Regulatory News In Brief

Mon, 09 Apr 2012 00:00:00 -0400

Blood Products Advisory Committee considers at-home HIV test; Protica QC personnel fail on supplement GMPs; FDA warns pregnancy test maker of GMP, labeling violations; FDA uncovers more tainted supplements sold online; NRDC request for BPA ban short on data.

Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says

Mon, 09 Apr 2012 00:00:00 -0400

FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.

Advisory Committee Recommends Mirabegron, But With Reservations About Efficacy And Safety

Fri, 06 Apr 2012 00:00:00 -0400

Will Advisory Committee Review Vindicate Pfizer’s Vyndaqel?

Fri, 06 Apr 2012 00:00:00 -0400

Pfizer’s orphan drug tafamidis will be reviewed by FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in May. The scheduling of a panel during a priority review is some indication FDA has concern, but the panels of outside experts are generally receptive to rare disease treatments.

Anthrax MedKit Initiative Could Learn From OTC Studies – NDAC

Thu, 05 Apr 2012 00:00:00 -0400

Mirabegron Must Overcome FDA’s “Special Safety Issues” At Advisory Committee

Tue, 03 Apr 2012 00:00:00 -0400

Agency says blood pressure and pulse elevation, neoplasm and other potential safety issues are a cause for concern for the proposed overactive bladder treatment, even though safety data appear reasonable.

Monkeys To Men: “Animal Rule” Study Of Cipro In Plague Gets Advisory Committee

Mon, 02 Apr 2012 00:00:00 -0400

NIH studied the antibiotic known for its efficacy against anthrax as a treatment for pneumonic plague in African Green Monkeys because clinical trials cannot be conducted in human beings.

CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement

Mon, 02 Apr 2012 00:00:00 -0400

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 02 Apr 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Obesity Drugs’ CV Risk Assessment Needs Hard Endpoints, Panel Tells FDA

Mon, 02 Apr 2012 00:00:00 -0400

When CV risk is assessed both before and after an obesity drug is approved, the first assessment could include subjectively determined events in the endpoint, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said during a session that included a vote in favor of outcomes trials for weight-loss drugs without a CV safety signal.

2012 FDA Advisory Committee Recommendations

Sun, 01 Apr 2012 00:00:00 -0400

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement

Fri, 30 Mar 2012 00:00:00 -0400

CV Trials For Obesity Drugs Won’t Be Conducive To Easy Interpretation, Panel Indicates

Thu, 29 Mar 2012 00:00:00 -0400

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will discuss design issues March 29 and vote on the need for pre-approval trials in drugs without a CV safety signal.

Conflict Of Interest Rules Removed In Draft Of House User Fee Bill

Mon, 26 Mar 2012 00:00:00 -0400

Reforms would end waiver caps for conflicts of interest, but whether they will solve the problems patient groups and others have with the advisory committee selection process is unclear. In a discussion draft, FDA could issue as many waivers of financial conflicts as it chose.

Obesity Drugs Panel To Mull Whether Products Without CV Signal Need Outcomes Trial

Mon, 26 Mar 2012 00:00:00 -0400

The Endocrinologic and Metabolic Drugs Advisory Committee also will evaluate methods for collecting cardiovascular risk information for obesity drugs with a CV safety signal, as FDA seeks input on when and how sponsors should evaluate their products.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 26 Mar 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Talon Marqibo’s Confirmatory Trial Plan May Need To Be Reworked

Mon, 26 Mar 2012 00:00:00 -0400

FDA advisory committee members express concern about the toxicity of Marqibo in the elderly patients expected to enroll in the Phase III confirmatory study for advanced acute lymphoblastic leukemia.

Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools

Mon, 26 Mar 2012 00:00:00 -0400

A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.

Cancer Therapies Should Be Held To Higher Bar In Maintenance Setting, ODAC Says

Mon, 26 Mar 2012 00:00:00 -0400

In their review of Merck/Ariad’s Taltorvic (ridaforolimus) for sarcoma patients with stable disease, members of FDA’s Oncologic Drugs Advisory Committee suggested the nature of maintenance therapy necessitates that efficacy be more robust, and toxicities less of a concern, than in the treatment setting.

Talon’s Marqibo Gets Lukewarm Endorsement From ODAC

Fri, 23 Mar 2012 00:00:00 -0400

A split Oncologic Drugs Advisory Committee vote moves Talon Therapeutics’ Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia one step closer to accelerated approval.

Gilead Quad’s Side Effects Profile, Novel Agents To Get Advisory Committee Review

Fri, 23 Mar 2012 00:00:00 -0400

FDA’s Antiviral Drugs Advisory Committee takes up the four-drug HIV-1 regimen, which includes two new agents, on May 11. The firm hopes to be able to sell the combination in part on its favorable side effects profile if the product is approved.

Repligen Imaging Aid SecreFlo May Provide Pancreatitis Patients An Endoscopy Alternative

Thu, 22 Mar 2012 00:00:00 -0400

A second read of Phase III data revealed statistically significant improvement in MRIs of pancreatitis patients for Repligen’s imaging aid SecreFlo. That finding will be tested by FDA’s Gastrointestinal Drugs Advisory Committee May 31.

Talon’s Marqibo Gets Lukewarm Endorsement From ODAC

Wed, 21 Mar 2012 00:00:00 -0400

Tale Of Two Sarcoma Drugs: ODAC Gives Nod To GSK’s Votrient, Thumbs Down On Merck/Ariad’s Taltorvic

Tue, 20 Mar 2012 00:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee deems the three-month median progression-free survival benefit with GlaxoSmithKline’s pazopanib clinically meaningful and views accelerated approval as a means for acquiring more efficacy data, particularly on symptom benefit. In contrast, panel says smaller median PFS benefit seen with Merck and Ariad’s ridaforolimus, coupled with its toxicities, makes it inappropriate in the maintenance setting.

Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill

Mon, 19 Mar 2012 00:00:00 -0400

Reforms merit one sentence, which would end waiver caps for conflicts of interest, but it is unclear whether it will solve the problems patient groups and others have with the advisory committee selection process.

Anti-NGF Trials Might Resume With Very Narrow Patient Populations

Mon, 19 Mar 2012 00:00:00 -0400

FDA’s Arthritis Advisory Committee suggests strictures that could be so strong as to discourage the resumption of clinical trials of Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 19 Mar 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Pediatric Pharmacokinetic Study Quality Standard Needs Rethinking, Cmte. Tells FDA

Mon, 19 Mar 2012 00:00:00 -0400

The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology rejects FDA’s proposed standard, which the agency and sponsors have been operating under for six months, for deriving the sample size in pediatric PK trials. The agency’s approach does not offer enough flexibility and may not fit all pediatric PK study programs, committee members said.

Regulatory News In Brief

Mon, 19 Mar 2012 00:00:00 -0400

FDA issues documents on advisory committee financial conflicts and scientific integrity. More regulatory updates.

Drugs For Severe Hyperbilirubinemia Could Face Long Development Program

Mon, 19 Mar 2012 00:00:00 -0400

FDA’s Gastrointestinal Drugs Advisory Committee notes difficulty in identifying endpoint during a March 13 meeting to discuss potential drug development pathways for the disease.

Lorcaserin Re-Review Expected To Address Risk/Benefit Trade-offs, Rat Tumors

Fri, 16 Mar 2012 00:00:00 -0400

Arena Pharmaceuticals gets new May 10 advisory committee review for its obesity therapy lorcaserin; execs say the recent positive review for competing Qnexa bodes well, and that this time around the risk/benefit profile for lorcaserin is much stronger.

Merck, GSK Sarcoma Drugs Bring Different Efficacy Stories To FDA Panel Review

Fri, 16 Mar 2012 00:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee will be asked to consider a two-week median progression-free survival benefit with Merck/Ariad’s Taltorvic in the maintenance setting, and a three-month PFS advantage with GSK’s Votrient in second-line treatment.

What’s Going On With Eliquis and Xarelto at FDA?

Thu, 15 Mar 2012 00:00:00 -0400

A key date was removed from FDA’s tentative advisory committee calendar. But a panel is still expected to review BMS’s anti-clotting agent Eliquis and a new indication for J&J’s Xarelto in ACS.

Truvada Pre-exposure Prophylaxis Claim Must Overcome Conflicting Subgroup Data

Tue, 13 Mar 2012 00:00:00 -0400

FDA’s Antiviral Drugs Advisory Committee will have to wrestle with the same types of questions about efficacy across various populations and implications for real world use that were raised by the AIDS Healthcare Foundation in a recent citizen petition opposing approval of Gilead’s sNDA for the new indication.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 12 Mar 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Dacogen Leukemia Indication Would Require New Clinical Trial, FDA Tells Eisai

Fri, 09 Mar 2012 00:00:00 -0500

The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia because the pivotal study failed to demonstrate a statistically significant survival benefit in the pre-specified primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.

Anti-NGF Drugs Clinical Holds Could Depend On What FDA Panel Thinks Of Standard Of Care

Thu, 08 Mar 2012 00:00:00 -0500

FDA’s Arthritis Advisory Committee will review troubling reports that the drugs, meant to relieve chronic pain from osteoarthritis and other diseases, may also destroy patients’ joints.

Regeneron’s Arcalyst Gets Advisory Committee For Niche Gout Indication

Wed, 07 Mar 2012 00:00:00 -0500

FDA’s Arthritis Advisory Committee will consider the interleukin-1 blocker for prevention of gout flares during initiation of uric-acid lowering therapy. Analysts say Arcalyst could have an easier time than Novartis’ Ilaris, which the panel felt had serious infection safety issues.

Dacogen Leukemia Indication Would Require New Clinical Trial, FDA Tells Eisai

Wed, 07 Mar 2012 00:00:00 -0500

Aegerion’s Lomitapide Gets Standard Review For Rare Genetic Cholesterol Disease

Tue, 06 Mar 2012 00:00:00 -0500

Aegerion is preparing for an advisory committee meeting after submitting its LDL-C lowering oral drug lomitapide to FDA for patients with homozygous familial hypercholesterolemia. The NDA was submitted ahead of that for Isis/Genzyme’s injectable competitor, mipomersen.