By John Carroll and Ryan McBride
Merck's ($MRK) struggling R&D group has been hit with yet another delay in its long and costly quest to gain an FDA approval for sugamaddex. The pharma giant said today that the FDA has cancelled an advisory committee review planned for Thursday, saying that the agency wants more time to "assess the results of the FDA's recently completed inspection of a clinical trial site."
The statement from Merck goes on to note that this is one of four sites which conducted a hypersensitivity study requested by the agency. Merck says it's pursuing discussions with the FDA to determine what it needs to do to complete the review.
More than a year ago Merck cited Bridion (sugammadex) as one of its top 5 late-stage drugs. But 5 years ago U.S. regulators rejected sugammadex, which Merck took on through its megamerger with Schering-Plough in 2009, over concerns about allergic reactions to patients. Merck and before it, Schering, have touted the compound as an important advance in anesthesia, a field that hasn't seen much innovation in years. And last March the FDA put off Merck yet again, asking for another three months to complete the review process.
For Merck, this latest setback reflects its continuing frustration in making progress on the R&D front. Even though it spends about $8 billion a year on R&D, the company has had a weak late-stage pipeline. The FDA recently snipped Merck's wings on suvorexant, a new sleep drug, demanding that it revise its NDA to limit any use to small doses. Merck, though, has had success gaining breakthrough drug status for its immunotherapy cancer treatment. And it won some widespread applause for naming Roger Perlmutter as its new R&D chief. Perlmutter is charged with restructuring the R&D division in hopes of spurring some fresh gains.
Merck already sells sugammadex--a member of a new class of selective relaxant binding agents--in 40 countries.
"Merck believes that sugammadex is an important treatment option for an unmet medical need in anesthesia, and we will work with the FDA on the next steps to bring this innovation forward to patients in the United States," said David Michelson, the head of global clinical development for neuroscience, Merck Research Laboratories.
- here's the press release