December of 2008 -- and since then, FDA staffers have expressed varying levels of concern about the perceived elevated risks of blood clots and allergic reactions of patients receiving the study medicine. Although approved in the EU, Bridion® has been a rather weak seller, due to lack of US market approval.
By my count, this is the third complete response letter (formerly called "non-approvables," or rejection letters) from FDA -- related to ex-CEO Fred Hassan's lead "five stars" candidate.
Yep -- Goin' down for the third time, then. It is now possible (probable, perhaps) this drug candidate will never see US FDA approvability, and thus never launch in the US markets. Ni-i-i-i-ice goin', Fast Fred!
Here is a bit of this morning's version of the Yahoo! story -- do go read it all:
. . . .[Merck] has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA’s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near future. . . .
I now think Merck should evaluate whether it should simply write off this US approval effort. Additional studies won't likely lead to blockbuster status. Ever. Perhaps a more-conservative approach would be to conduct some cheap post-hoc meta analysis of the drug's overall emerging experience in the EU, then report to FDA if -- over time -- it looks like the clot and allergic reaction data are more reassuring, when observed over a much larger set of patient on-dosings. Just a thought. But this is a major dis-connect from Fred's endless hype. It seems unapprovable in the US.