BMS unexpectedly pulls application for hep C drug
- On Tuesday, Bristol-Myers Squibb unexpectedly announced that it would be pulling its New Drug Application (NDA) to the FDA for asunaprevir as part of a dual hep C regimen of daclatasvir and asunaprevir.
- Daclatasvir and asunaprevir were being submitted for the treatment of HCV genotype 1b for U.S. patients.
- BMS will still seek FDA approval of daclatasvir, an NS5A complex inhibitor that is being tested for treatment of HCV patients with a high need throughout the world.
In a press release, BMS stated that it was abandoning its application due to "the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S."
That's almost certianly a reference to Gilead Science's blockbuster hep C cure Sovaldi. Gilead plans to release a newer version of Sovaldi that doesn't require the concurrent use of ribavarin and interferon in the coming months -- which may be why BMS decided to abandon its current project, since one of the main benefits of its own combo therapy is that it doesn't require interferon and ribavarin.
- Bristol-Myers Squibb Bristol-Myers Squibb Statement about Asunaprevir in the U.S.