Bristol-Myers heads back to the FDA with its long-delayed hep C drug

Bristol-Myers' Doug Manion

Bristol-Myers Squibb ($BMY) is finally in line for FDA approval for its once-rejected hepatitis C daclatasvir, angling to take third place among companies with next-generation cures for the virus.

The FDA accepted Bristol-Myers application for a combination of daclatasvir and Gilead Sciences' ($GILD) blockbuster Sovaldi as a 12-week treatment for hep C genotype 3, the second most common strain after genotype 1. In a 12-week Phase III trial, the combo cured 90% of treatment-naive patients and 86% of those who had failed on other therapies, charting a 96% cure rate in hep C sufferers without cirrhosis.

The agency promises to hand down a final decision on the combination treatment within 6 months, Bristol-Myers said, giving the company a do-over opportunity after its best-laid plans in hep C went awry last year.

Bristol-Myers developed daclatasvir, an inhibitor of the protein NS5A, to be used in tandem with its own asunaprevir, which blocks NS3/4A to halt viral replication. But, as rivals Gilead and AbbVie ($ABBV) barreled toward the U.S. market with cocktail treatments of their own, the company abandoned its stateside plans with the pairing, withdrawing its asunaprevir application in October. That hamstrung the regulatory prospects for daclatasvir, which Bristol-Myers had submitted as part of a combination, and so the FDA summarily rejected that drug in November.

Now the company is picking up the pieces of its U.S. hep C strategy, homing in on genotype 3. Harvoni, Gilead's top-selling combination of Sovaldi and an in-house NS5A inhibitor, is approved for genotype 1, and the same goes for AbbVie's competing Viekira Pak. Bristol-Myers contends that there remains a huge unmet need, pointing out that genotype 3 is generally more aggressive and quick to spur kidney damage.

"Approximately 9% to 12% of HCV patients in the U.S. have genotype 3," Bristol-Myers head of specialty development Douglas Manion said in a statement. "That's thousands of individuals in the U.S. who historically have had limited treatment options requiring at least 24 weeks of treatment."

- read the statement

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