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FDA Declines to Approve Sugammadex (Bridion) for Third Time
In its 2015 first-quarter financial review, Merck acknowledged that it has once again received a complete response letter (CRL) from the FDA for sugammadex injection (Bridion), an investigational drug for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
This is the medication’s third rejection by the FDA, which has never been satisfied by the safety data concerning hypersensitivity. The agency’s first “thumbs down” came 7 years ago amid concerns about a possible association with allergic reactions and bleeding.
The long-stymied development program for sugammadex has become an enduring embarrassment for Merck, which has sought to distance itself from a long track record of clinical setbacks.
In March, Reuters reported that the company expected to be denied approval for sugammadex once again. A March 18 meeting of an independent FDA medical advisory panel to discuss the company’s resubmitted marketing application had been canceled, Merck said at the time, adding that it would continue to work with the FDA as the agency completed its review.
Summamadex was originally developed by Schering Plough, a rival drug-maker acquired by Merck in 2009, and has been touted by the two companies for years as a potential major advance in speeding the recovery of patients from anesthesia.
Sugammadex injection is currently marketed in more than 60 countries outside the U.S.
Sources: Merck; April 28, 2015; FierceBiotech; April 28, 2015; and Reuters; March 13, 2015.