Posts Tagged ‘FDA’

May 16th, 2014

FDA Turns Back Novel Drug for Acute Heart Failure

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. The FDA decision was not unexpected since earlier this […]

May 13th, 2014

FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with […]

May 8th, 2014

Novel Antiplatelet Agent Vorapaxar Gains FDA Approval

The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (MI), 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 has experienced nearly as many […]

May 5th, 2014

FDA Comes Out Against Aspirin for Primary Prevention

In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for primary prevention for heart attack or stroke. The announcement follows the FDA’s rejection on Friday of Bayer Healthcare’s decade-old petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter] Aspirin is still widely used for primary prevention. Many physicians, […]

March 27th, 2014

FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug

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 (HF). The once highly promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval […]

March 25th, 2014

FDA Reviewers Recommend Against Approval for Novartis Heart Failure Drug

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 Advisory Committee will discuss the biologics license application (BLA) […]

March 12th, 2014

Clinical Trials For Diabetes Drugs Need To Consider Heart Failure

Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of  prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. That belief is no longer widely held, however, and the FDA now requires cardiovascular […]

February 14th, 2014

FDA Once Again Rejects New Indication For Rivaroxaban

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 […]

February 13th, 2014

FDA Advisory Panel Recommends Against Approval of Cangrelor

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, for the […]

February 11th, 2014

FDA Investigating Heart Failure Risk Linked to Saxagliptin

The FDA said today that it is conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin, a dipeptidyl peptidase 4 inhibitor, is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, Bristol Myers-Squibb.) The investigation stems […]