Pharmaceutical Approvals Monthly from Elsevier Business Intelligence

FDAer Eyes Improvements In Anticoagulant Trial Design

b.silverman@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

The challenges seen in the review of the new generation of oral anticoagulants suggested some avenues for improved trial design to Division of Cardiovascular and Renal Products Deputy Director Stephen Grant. The difficulty of measuring and maintaining the effectiveness for the active comparator, warfarin, in oral anticoagulant trials was a major sticking point in the review of Johnson & Johnson/Bayer AG’s novel oral anticoagulant Xarelto (rivaroxaban) for one of the most commercially significant anticoagulant markets, prevention of stroke and systemic embolism in patients with atrial fibri...

Merck Talks About Its Pipeline Post-Singulair

l.lamotta@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

With its blockbuster asthma drug Singulair going off-patent at the end of the year, Merck is looking to a few key drugs to fill the revenue gap in the coming years, the company said at a recent Deutsche Bank Healthcare conference.

Acorda R&D Day Explores Pipeline Opportunities

l.lamotta@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

Acorda Therapeutics highlighted the other indications it has in the works for its MS drug Ampyra, as well as several early-stage compounds in other neurological indications.

Boehringer Will Test How Pradaxa Stacks Up To The Competition In Real-World Study

e.hayes@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

Global observational study is assessing real-world experience with Pradaxa and other anticoagulants in patients with newly diagnosed atrial fibrillation who are at risk of stroke. Results are due in 2020.

Current Class Of Risk Evaluation & Mitigation Strategies

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

Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS.

Depomed Hot Flash Drug May Finally Be On Its Way To FDA

e.hayes@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

Despite the product’s rocky history, Depomed says it is ready to file its non-hormonal hot flash treatment Serada (extended-release gabapentin) based on a recent meeting with FDA. But a mixed Phase III dataset raises doubts about approvability.

Xarelto Reviewers

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

FDA staff who participated in the review of Johnson & Johnson/Bayer’s oral anticoagulant rivaroxaban for prevention of stroke and systemic embolism in patients with atrial fibrillation

GTx Restarts Development Of Prostate Cancer Drug Capesaris

l.lamotta@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

GTx managed to convince FDA to lift its clinical hold, arguing the mid-stage prostate cancer drug would be safe to test again in patients at lower dosages than before.

Novartis Revises U.S. Regulatory Strategy For Key Respiratory Drug

j.merrill@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

The Swiss drug maker says it has agreed with FDA on a Phase III trial design for the combination respiratory drug QVA149 and expects to file in late 2014; plan now calls for testing a twice-daily dose in addition to once-daily.

Pfizer’s Pride-And-Joy Pain Drug Lyrica Slips In Two New Phase III Trials

e.hayes@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

One failed study tested Lyrica in a subset of difficult-to-treat patients in the approved indication of diabetic neuropathy, while another explored its use in neuropathic pain related to HIV.

Sanofi/Genzyme MS Drug Lemtrada Scores High Against Rebif

s.haley@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

Genzyme, a Sanofi company, set the bar high for its multiple sclerosis contender by stacking it up against Roche’s interferon beta-1a in Phase III trials and got the results it was looking for, with a filing set for this quarter.

Selected Active Cancer Vaccines In Development

s.haley@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

A sampling of cancer immunotherapeutics, also called vaccines, in late-stage development illustrates the variety of approaches and mechanisms in play.

The Xarelto Trials That Might Have Been

b.silverman@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) was cleared for stroke prevention in atrial fibrillation patients unencumbered by new post-marketing studies – but not for lack of suggestions. FDA reviewers had urged further studies on topics ranging from alternate dosing regimens and reversal of drug activity to transitioning to warfarin.

Xarelto Development Timeline

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

A chronology of the development of Johnson & Johnson/Bayer’s anticoagulant for atrial fibrillation, the second submission for the drug.

New Molecular Entities Approved In 2012

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

Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.

FDA’s ANDA Approvals

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

Product Sponsor Date Approved Application No. Escitalopram oxalate, EQ 5 mg base/5 mL, solution Aurobindo 4/2/2012 79-062 Acetaminophen/oxycodone HCl, 325 mg/7.5 mg and 325 mg/10 mg, tabs.

Cancer Vaccines Headed For Mainstream

s.haley@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

No longer the odd cousins of traditional pharmaceutical applications, a host of therapeutic cancer vaccines is working through late-stage trials with real, life-extending data already reported and the potential to create a lot of action in the oncology sector.

April Full Approvals

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

Full approvals of NDAs and BLAs.

April Supplemental Approvals

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

Chart lists efficacy supplements and labeling supplements selected by the editors of “Pharmaceutical Approvals Monthly.” This is not a comprehensive list of all supplemental approvals.

Biologics Approved In 2012

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

FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.

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.

Xarelto Tested FDA’s Comparative Efficacy Powers, But Conservative View Prevailed

b.silverman@elsevier.com — Tue, 01 May 2012 00:00:00 -0400

J&J/Bayer’s Xarelto tested the limits of FDA’s policy on comparative efficacy, thanks to suboptimal use of the active comparator, warfarin, and the introduction of a new competitor, Pradaxa. In the medical reviewers’ view, new therapies should be as effective as existing therapies used skillfully, but division leadership would withhold approval only if the new drug were clearly inferior to approved agents.

Estimated FDA User Fee Review Goals For Pending NDAs/BLAs

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

Estimated user fee goals for FDA action on publicly disclosed NDAs, BLAs and efficacy supplements are calculated based on the date of receipt and assignment to standard or priority review. Resubmissions with significant new data or analyses have a 6-month goal.

“Complete Response” Letters

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

FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters on Aug. 11, 2008. The following chart lists “complete response” actions that were recently announced, as well as still-pending “approvable” and “not approvable” actions.

March ANDA Approvals

Wed, 18 Apr 2012 13:01:15 -0400

Full and tentative generic drug approvals.

AACR Showcases Early Cancer Drugs, Early Use Of Biomarker Strategies

s.haley@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

At the American Association for Cancer Research annual meeting in Chicago, data were presented on early-stage projects, some of them for the first time, as AACR displayed its growing enthusiasm for translational medicine.

Allergan Seeks To Extend Botox Use To Overactive Bladder

j.merrill@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

During an R&D day March 28, Allergan highlighted its growth strategy for Botox, which includes expansion into new indications like overactive bladder; the company submitted an sBLA for the indication.

BIND Nanotherapy Shows Early Cancer Efficacy In The Clinic

s.haley@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Strong preclinical data for BIND-014, docetaxel-carrying particles engineered using BIND’s Accurin platform, translated into positive results against tumors not usually vulnerable to the cancer drug, the company reported at a late-breaker poster session of the American Association for Cancer Research annual meeting.

Bleeding Rates In TRA-2P Further Dim Outlook For Merck’s Vorapaxar

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Outcomes study of about 25,000 patients shows novel antiplatelet drug reduces events but also increases major bleeding, including intracranial hemorrhage.

Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says

s.sutter@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.

Genzyme/Isis’ Long-Awaited Kynamro NDA May Allay Liver Toxicity Fears

w.diller@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Sanofi’s Genzyme business unit and Isis submitted an NDA for mipomersen, a first-in-class cholesterol-lowering antisense drug, in an orphan population of high-risk patients with a rare genetic cardiovascular disease – with an assist from three Phase III clinical trials from other, larger, high-risk populations, to help inform regulators.

GSK Plans To File Once-Weekly GLP-1 Albiglutide By Year-End

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

GSK/Human Genome Sciences’ once-weekly injectable GLP-1 agonist albiglutide succeeds in a non-inferiority study and should be filed in late 2012. But analysts critique efficacy relative to the competition and some say the diabetes drug will come to the market too late.

Janssen Plans New U.S. Filing For Xarelto Based On Positive EINSTEIN-PE Results

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

In study of almost 5,000 patients, Janssen/Bayer’s novel anticoagulant proves non-inferior on efficacy compared to old standard of care, with significantly less major bleeding. A mostly one-drug, oral approach could help differentiate the drug from rivals in venous thromboembolism prevention.

March Full Approvals

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

Full approvals of NDAs and BLAs.

March Supplemental Approvals

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

Chart lists efficacy supplements and labeling supplements selected by the editors of “Pharmaceutical Approvals Monthly.” This is not a comprehensive list of all supplemental approvals.

Oncology Review Division At The Head Of The Pack – But Can The Others Keep Up?

b.silverman@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Analysis of drug review performance by division finds Cardiovascular & Renal Drugs Division to occupy the lower end of the spectrum. Staffing appears to be a vital component of review performance, giving weight to the researchers’ warning of impending wholesale staff turnover.

Positive Early Results For Addex Parkinson’s Drug Dipraglurant Spur Hopes For Deal

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

In a small, short Phase IIa study, an oral inhibitor of mGluR5 proved effective at reducing dyskinesia caused by levodopa. If future trials are positive, the drug would have a significant positive impact on Parkinson’s patients, says the Michael J.

Profile Of Viiv’s Unboosted Dolutegravir Emerges With First Phase III Results

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Viiv Healthcare/Shionogi’s once-daily, unboosted integrase inhibitor dolutegravir is efficacious and well-tolerated in the first of four Phase III HIV trials to report, a study of treatment-naïve patients. Drug poses a competitive threat to Merck’s blockbuster Isentress and Gilead’s elvitegravir, part of the four-in-one “Quad” pill.

Sanofi/Regeneron’s PCSK9 Data Show Robust LDL Reduction, But Prompt Call For Outcomes Data

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

Novel inhibitor of PCSK9 lowers LDL cholesterol far beyond what can be achieved by statins. Investigators report reductions of 40% to 72% in new Phase II trial.

Targacept, AstraZeneca Face Another Failure With NNR Class

e.hayes@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

The Targacept/AstraZeneca partnership faces another major setback as they decide not to file their neuronal nicotinic receptor modulator TC-5214 in major depressive disorder. Targacept CEO chalks the trial failure up to the gray areas of depression trial design.

Threshold Cancer Drug May Successfully Target Hypoxia

s.haley@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

In combination with gemcitabine, TH-302 produced positive Phase IIb results in treatment naïve pancreatic cancer patients, according to late-breaking data presented April 2 at the AACR meeting in Chicago.

Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says

b.silverman@elsevier.com — Sun, 01 Apr 2012 00:00:00 -0400

FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.

Review Performance By The Numbers

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

A breakdown of performance metrics for the eight CDER review divisions analyzed by the Tufts Center for the Study of Drug Development.

Estimated FDA User Fee Review Goals For Pending NDAs/BLAs

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

“Complete Response” Letters

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

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.

Current Class Of Risk Evaluation & Mitigation Strategies

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

New Molecular Entities Approved In 2012

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

Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.

Biologics Approved In 2012

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

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

e.hayes@elsevier.com — Thu, 01 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.