BMS Pulls NDA for Hepatitis C Combo Drug

Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population.

“We feel that [the combination] would not be competitive in the U.S.,” company spokeswoman Carrie Fernandez said. Daklinza (daclatasvir) and asunaprevir treat patients specifically with genotype 1b disease, while most U.S. patients have genotype 1a, she added.

The epidemiology of hepatitis C is different worldwide, Fernandez explained. In Egypt, for example, it’s predominantly genotype 4, while in Europe, many patients have genotype 3. This drug combo is better served in a population such as Japan’s, where 70 percent of the hepatitis C patient population has genotype 1b, she said.

Fernandez stressed that BMS is still seeking FDA approval of daclatasvir, which recently received the European Medicines Agency’s nod for use in combination with other hepatitis C drugs.

The combination product would have faced significant adherence hurdles, she said, including the fact that it requires 24 weeks of administration. Other hepatitis C drugs, including Gilead Sciences’ Sovaldi (sofosbuvir), require only 12-week regimens, which patients will likely find easier to take.

ISI Group analyst Mark Schoenebaum says that investors expressed little confidence in revenue expectations for the combo, though he does expect BMS to receive approval for a three-drug regimen containing Daklinza and asunaprevir, along with another investigational drug, sometime in the second half of next year. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.