“Still Abed?”: No New Date For FDA Review Of Latest Sugammadex Safety Data — Now A Mid-2014 US Launch?

Ed Silverman over at Pharmalot.com is reporting that FDA has cancelled the July 18, 2013 advisory committee meeting to review the latest data on Bridion/Sugammadex.

And, that, in turn, makes a 2013 launch unlikely, now — it may well be into 2014. And that puts it well over six years behind schedule vis-a-vis Ex-Schering Plough CEO Hassan’s claims — in 2008.

Here’s Ed/Bloomberg — do go read it all:

. . . .A Food and Drug Administration advisory panel was set to meet July 18 to discuss sugammadex, which enables the muscle movement necessary in a patient to extract a breathing tube after surgery. The trial site the FDA is concerned with is one of four where potential allergic reactions associated with the drug were studied, Merck said in a statement today.

Merck has been pursuing a second chance for the drug in the U.S. after the FDA rejected sugammadex in 2008 because of the potential for allergic reactions and bleeding. . . .

We will — as ever — keep you posted.


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