Bristol-Myers Squibb Withdraws NDA For Asunaprevir-Daclatasvir In HCV

Bristol-Myers Squibb (BMS) is withdrawing its New Drug Application (NDA) for asunaprevir in combination treatment with daclatasvir for the treatment of HCV genotype 1b patients. BMS announced the move in a press release, citing the rapidly evolving HCV landscape in the U.S. The company stated that it will continue its investigations of daclatasvir in combination treatments and pursue Food and Drug Administration (FDA) approval of daclatasvir.

Asunaprevir Withdrawal

BMS states that its HCV strategy is shaped by local markets, and that this treatment combination in particular was indicated specifically for Japanese patients. Indeed, Japan approved daclatasvir and asunaprevir in July 2014, in order to meet the needs of Japanese patients. The company states that the treatment may cure patients in other markets “where the HCV patient population is similar to Japan.”

BMS states that in the EU, daclatasvir in combination with several other treatments (not Asunaprevir) is approved for genotypes 1, 2, 3, and 4, in turn suggesting the potential benefits daclatasvir-based regimens could bring to HCV patients in the U.S. and other countries, as well.

Asunaprevir Competition

While BMS states that the U.S. market is not right for asunaprevir, competing HCV drugs may have informed its decision. Indeed, Gilead has applied for approval of Sovaldi (sofosbuvir) and ledipasvir, about which the FDA is expected to reveal its decision by October 10. AbbVie submitted an NDA for ABT-450, ABT-267, and ABT-333. Merck is also expected to make some strides in the HCV space following its acquisition of Idenix’s clinical-phase HCV drugs, including IDX21437, IDX21459, and samatasvir.

BMS Strategy

In its announcement, BMS focused its discussion on its plans for daclatasvir, stating that it will submit additional data to the FDA on its ongoing clinical program. Those studies include difficult patient populations such as patients infected with HIV, those who are pre- and post-liver transplant, and those with HCV genotype 3. The company will present new data from those investigations at the annual meeting of The American Association for the Study of Liver Diseases (AASLD).

BMS Activities

BMS has been active lately in partnering with other companies and academic entities. It recently announced a collaboration with the University of Texas MD Anderson Cancer Center and Novartis to study Opdivo (nivolumab) in hematologic malignancies and non-small cell lung cancer (NSCLC), respectively. Opdivo is a checkpoint inhibitor that exposes tumor cells to the immune system response. BMS is conducting several trials with the agent on several types of tumors.