A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

The US Food & Drug Administration will be convening an advisory committee to review Correvio Pharma Corp.’s anit-arrhythmic drug vernakalant in December – a dozen years after the Cardiovascular & Renal Drugs Advisory Committee first considered the product for approval.

That 2007 meeting ended in a vote in favor of approval of the IV therapy for conversion of atrial fibrillation to normal sinus rhythm. The FDA, however, ended up rejecting the application – due to safety concerns, including potential signals of pro-arrhythmic effects. That decision came in 2008, when FDA still issued “approvable” letters, making it seem possible that the drug would reach the market relatively soon. (Also see "Astellas/Cardiome’s Kynapid “Approvable”" - Pink Sheet, 11 Aug, 2008.)

That didn’t happen, obviously. At the time, the drug – developed by Correvio’s predecessor company Cardiome Pharma Corp. – was licensed to Astellas Pharma Inc. Despite the setback at the FDA, Merck & Co. Inc. stepped in in 2009 to license global rights to therapy, and then assumed US rights as well when Astellas gave up on the project after a patient death led to a clinical hold. Merck in turn gave up on the drug in 2012.

In the meantime, though, vernakalant was approved in Europe under the trade name Brinavess. And now the FDA is asking the Cardio-Renal panel to meet on 10 Dec. to review what is technically a resubmission of the NDA for the drug.

It is in many ways an apt way for the FDA to wrap up the year, given the preponderance of advisory committee meetings in 2019 that amounted to second-chances for panels to opine on applications that had been considered years earlier.

Most recently, the Endocrinologic & Metabolic Drugs Advisory Committee voted in favor of a cardiovascular outcomes claim for Amarin’s fish-oil derived Vascepa triglyceride therapy – six years after rejecting a claim based on triglyceride data alone. (Also see "Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod" - Pink Sheet, 14 Nov, 2019.)

Earlier in the year, the Pulmonary Allergy Drugs Advisory Committee revisited a different 2013 review, for the inhaled cystic fibrosis therapy Bronchitol (mannitol). (Also see "Bronchitol Gets Narrow Approval Vote From Advisory Cmte., Leaving US FDA Host Of Issues To Consider" - Pink Sheet, 8 May, 2019.)

The Bone, Reproductive & Urologic Drugs Advisory Committee also held a re-review of sorts when it met to discuss the continued marketing status of AMAG Pharmaceuticals Inc.’s Makena. Thirteen years after initially considering the application, the panel voted that it no longer sees substantial evidence of efficacy for the pre-term labor therapy. (Also see "Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA" - Pink Sheet, 29 Oct, 2019.)

But none of those meetings comes close to the longest gap between discussions of the same topic by the same committee during 2019. That honor goes to Antimicrobial Drugs Advisory Committee, which met April to discuss the continued marketing status of injectable bacitracin. The committee voted that the approved indication should be withdrawn – just as it did 35 years ago when it met to consider the DESI status of the product in 1984. (Also see "Injectable Bacitracin’s Lone Indication Should Be Revoked, US FDA Panel Says" - Pink Sheet, 28 Apr, 2019.)