Five years after Merck was handed a rejection for sugammadex, the FDA has come back with another complete response letter stiff-arming the pharma giant's latest attempt to get marketing authorization for the anesthesia drug.
According to the pharma giant ($MRK), this latest black eye for the trouble-prone R&D group comes after the FDA "raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008." The company is examining the letter and will respond, eventually. But there is a hint about what could have gone wrong in Merck's release. Back in July, Merck noted that the FDA had canceled an advisory panel review of the drug after deciding that the agency needed to assess an inspection of a clinical trial site conducting the hypersensitivity study.
The latest setback at Merck R&D is likely to trigger a fresh assault from company critics who have been calling for a major retooling of the massive research division, which spends more than $8 billion a year. In recent months the company has had to wrestle with the FDA's insistence that Merck rewrite its NDA on the sleep drug suvorexant, reducing the initial dose to a level the company is on record as saying doesn't work. Analysts were also startled by the news earlier this year that Merck was delaying its application for the osteoporosis drug odanacatib.
Months later, R&D chief Peter Kim was gone, and Roger Perlmutter took his place.
Perlmutter has been working to create a new narrative for the company, which revolves around the early success of its promising PD-1 cancer program for MK-3475. He's been discussing plans to strip unnecessary layers of bureaucracy out of the organization. But the legacy issues continue to blight any progress he has made. And critics like Seamus Fernandez at Leerink--unsatisfied by Perlmutter's fine tuning--have been clamoring for a top-to-bottom reorganization that can cut more than a billion dollars out of the research budget.
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.
"We believe sugammadex is an important innovation, and will work closely with the FDA to bring this product to hospitals, surgeons, anesthesia professionals and patients in the United States," said Dr. David Michelson, head of global neuroscience clinical development, Merck Research Laboratories.
- here's the press release