BMS Withdraws FDA Application for Hepatitis C Drug Asunaprevir

Bristol-Myers Squibb unexpectedly announced this week that it will no longer seek U.S. Food and Drug Administration (FDA) approval for its experimental hepatitis C virus (HCV) protease inhibitor asunaprevir, despite promising results in clinical trials to date.

BMS's interferon-free regimen of asunaprevir (brand name Sunvepra) plus the HCV NS5A inhibitor daclatasvir (Daklinza) wasrecently approved in Japan, where most people with chronic hepatitis C have genotype 1b. This dual combination was shown to be highly effective against genotype 1b, however it is less so against harder-to-treat genotype 1a, which is more common in the U.S. Daclatasvir was recently approved in Europe and is awaiting FDA approval. Studies have shown that it works very well in combination with Gilead Sciences' sofosbuvir (Sovaldi).

Below is an edited excerpt from Bristol-Myers Squibb announcement about its asunaprevir decision.

Bristol-Myers Squibb Statement about Asunaprevir in the U.S.

October 7, 2014 -- Princeton, N.J. -- Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb (NYSE:BMY) has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.

The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3, and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.

We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

10/8/14

Source

Bristol-Myers Squibb. Bristol-Myers Squibb Statement about Asunaprevir in the U.S. Media announcement. October 7, 2014.