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.