The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly…
FDA Comes Out Against Aspirin To Prevent First Heart Attacks
May 5, 2014 by 1 Comment
In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter]…
FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug
March 27, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last…
FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
March 25, 2014 by 1 Comment
Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday the FDA’s Cardiovascular and Renal Drugs…
Apixaban Gains Indication For DVT Prophylaxis After Knee And Hip Replacement Surgery
March 14, 2014 by Leave a Comment
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. DVT can lead to the life-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously…
FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade
March 7, 2014 by Leave a Comment
In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs. Last month Regeneron disclosed that it had been “advised by the FDA that…
Aegerion Warns About Negative Impact Of DOJ Investigation
March 5, 2014 by Leave a Comment
Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid…
FDA Once Again Rejects New Indication For Rivaroxaban
February 14, 2014 by Leave a Comment
The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…
FDA Advisory Panel Recommends Against Approval Of Cangrelor
February 12, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI. The panel also voted unanimously to reject a second indication… … Click…
FDA Investigating Heart Failure Risk Linked To Onglyza
February 11, 2014 by Leave a Comment
The FDA said today that it was conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb.) The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial in which more…
FDA Evaluating Safety Of Testosterone
January 31, 2014 by Leave a Comment
The FDA said today that it was evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy. … Click here to read the full post on Forbes. …
European Setback For Novartis Heart Failure Drug
January 24, 2014 by Leave a Comment
European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which…
Stent Remains Available Despite Trial Showing Dangers
January 23, 2014 by 1 Comment
A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes. … Now, in a paper published in BMJ, a group of physicians led by Rita Redberg say that by not removing Wingspan from the market the…
FDA Panel Once Again Rejects New Indication For Rivaroxaban
January 16, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. … Click here to read the full post on Forbes….
Merck’s Vorapaxar Gets Positive FDA Review
January 13, 2014 by Leave a Comment
A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with…
FDA Advisory Panel To Review New Heart Failure Drug From Novartis
January 7, 2014 by Leave a Comment
A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the…
FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)
January 3, 2014 by Leave a Comment
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. n December 30 the FDA posted a request for public comment on a…
Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
December 16, 2013 by Leave a Comment
Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…
FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific
December 12, 2013 by Leave a Comment
The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the…
Boston Scientific May Face A Tough FDA Panel
December 10, 2013 by Leave a Comment
On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response…
FDA Removes Restrictions On Avandia
November 25, 2013 by Leave a Comment
In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said…
FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent
November 25, 2013 by Leave a Comment
It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test. The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,”…
No Evidence That Statins Impact Cognitive Function
November 18, 2013 by Leave a Comment
In 2012 the FDA revised the label of statins to include a warning about reports that the drugs had been linked to memory loss or confusion. The FDA action appeared to be based largely on case reports. Despite concerns about this topic that have appeared sporadically in recent years, no high-quality review of the topic has appeared until now….
No Evidence That Statins Impact Cognitive Function
November 18, 2013 by Leave a Comment
In 2012 the FDA revised the label of statins to include a warning about reports that the drugs had been linked to memory loss or confusion. The FDA action appeared to be based largely on case reports. Despite concerns about this topic that have appeared sporadically in recent years, no high-quality review of the topic has appeared until now….
The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT
November 14, 2013 by Leave a Comment
Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…
Recent Comments