Posts Tagged ‘FDA Advisory Committee’

April 16th, 2015

Cangrelor Finally Gets Nod From FDA Advisory Panel

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization. The news follows a decade of efforts to develop the drug — a potent, fast-acting, and reversible  antiplatelet agent. After the failure of two […]

February 10th, 2014

FDA Reviewers Deliver Split Opinion on Cangrelor

FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and provide sufficient reason to “refuse approval…on that fact alone.”  But two other reviewers recommend approval. On Wednesday the FDA’s Cardiovascular and […]

January 17th, 2014

FDA Panel Once Again Rejects ACS Indication for Rivaroxaban

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS)  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. Although originally the subject of high praise when […]

January 16th, 2014

FDA Advisory Panel Votes in Favor of Approval for Merck’s Vorapaxar

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. The committee voted in favor of the drug […]

January 13th, 2014

Merck’s Vorapaxar Gets Positive FDA Review

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 […]

December 12th, 2013

FDA Panel Gives Support to Left Atrial Appendage Closure Device

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 […]

October 10th, 2013

CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel

The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about the CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that the […]

June 7th, 2013

FDA Advisory Panel Backs Looser Restrictions on Avandia

After two days of deliberation an FDA advisory panel has recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline [GSK]) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. […]

June 4th, 2013

With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial

The FDA has released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by […]

May 24th, 2013

Spinning RECORD: Battle Over Rosiglitazone Heats up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline [GSK]). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at […]