BMS withdraws application for FDA approval for HCV treatment

Bristol-Myers Squibb (BMS) has announced it is no longer pursuing approval from the US Food and Drug Administration (FDA) for approval of the dual regiment of daclatasvir and asunaprevir for the treatment of patients with hepatitis C (HCV) genotype 1b.

Citing the rapidly expanding treatment landscape for the condition, BMS has decided to withdraw its new drug application for asunaprevir, an NS3/4A protease inhibitor.

However, the company will continue to seek FDA approval for daclatasvir, a potent pan-genotypic NS5A complex inhibitor. This is currently being investigated globally in multiple treatment programmes for patients with an unmet need.

BMS said its strategy regarding HCV drugs has always focused on the unique medical requirements in each local market, highlighting the fact the dual regimen of the two medicines has been approved in Japan to bring patients there the first all-oral interferon and ribavirin-free treatment option.

In the EU, daclatasvir has recently been approved for use in combination with other drugs across genotypes 1, 2, 3 and 4, and for the treatment of adults with HCV infection.