The FDA has slapped down Bristol-Myers Squibb's ($BMY) closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.
According to the big biotech, the initial marketing application for daclatasvir, an NS5A inhibitor, included its use in combination with the NS3/4A protease inhibitor asunaprevir--a combo that Bristol-Myers recently scuttled in the U.S. Now regulators are demanding more data for daclatasvir in combination with other antiviral agents for the treatment of HCV.
There's no immediate word on just how long the drug could be delayed in the U.S. before it hits the fast-changing hep C market. Bristol-Myers says it is "in discussions with the FDA about the scope of these data."
"Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible," says Bristol-Myers R&D chief Francis Cuss.
Bristol-Myers--which fell behind Gilead's Sovaldi early on--had pursued an international development program for daclatasvir and asunaprevir, with a close eye on markets like Japan which have large populations of genotype 1b patients. The company won a landmark approval for the combo in Japan back in July, ushering in a new interferon-free regimen that is helping to rewrite the standard of care in the field.
Bristol-Myers was initially dealt a major blow when its nucleotide polymerase inhibitor--or "nuc"--blew up in the clinic a couple of years ago. Gilead, meanwhile, won an approval for a combination of Sovaldi (an NS5B blocker) and ledipasvir, its NS5A inhibitor. AbbVie and Merck have been working hard to close the gap with late-stage cocktails of their own that promise to further disrupt a market that has stunned payers with the introductory price of $84,000 for Sovaldi. That's a race that is squeezing out Bristol-Myers from the world's biggest drug market.
- here's the release