Will Bridion® (sugammadex) FINALLY Win Approval (On Fourth Try: 12.19.2015) — At FDA?

We have covered, for at least seven years, the intrepid path of sugammadex, one of former Schering-Plough CEO Fred Hassan‘s 2007-2008 “Five Stars.” Back then he was touting a likely 2009 approval. If he’s lucky, it might — just might — make approval in the US before the end of 2015. And even then, the concerns with rather rare, but troubling, allergic reactions in the Operating Room Suites seem to continue — in Europe, where it has been approved for over three years, now. This is clearly going to be an immaterial US franchise for Kenilworth, if approved, but it is some good news, nonetheless.

Here is a bit from BioPharmaDive, on it:

. . . .Seven months ago, Bridion was rejected by the FDA’s reviewing panel for the third time. The concern was ‘hypersensitivity’ to the drug, and because the drug had already been used in the E.U. for some time, there were numerous case reports to attest to this risk. . . .

The FDA is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of Bridion is December 19, 2015. . . .

It is (in my opinion) probable that the US label-copy will contain strong warnings — about watching for patients’ allergic reactions while under heavy sedation, in the OR. Onward, we go, in any event — on a perfect fall Monday afternoon!


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