FDA Requires Additional Data On Bristol-Myers Squibb Company' Hep C Daclatasvir

Published: Nov 26, 2014

FDA Requires Additional Data On Bristol-Myers' Hep C Daclatasvir

November 26, 2014

By Riley McDermid, BioSpace.com Breaking News Editor

The U.S. Food and Drug Administration has denied approval for Bristol-Myers Squibb Co ’s new hepatitis C drug, daclatasvir, in combination with other antivirals, over concern that it did not have enough information about how it works.

The company originally sought FDA permission for the NS5A inhibitor to be used in a drug cocktail with its experimental hepatitis C drug asunaprevir. Now, however, the FDA has said it cannot approve daclatasvir as part of a combination regimen because it does not have enough data.

“The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor,” said the company in a statement. “Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.”

Bristol-Meyers has conducted clinical trials of the combo in Japan, treating patients over 24 weeks and seeing cure rate of around 85 percent. Reuters pointed out Wednesday that those trials, while promising, still fall short in the competition ring.

“Combinations being developed by rival drugmakers have demonstrated cure rates well in excess of 90 percent with just 12 weeks of therapy, and they are pursuing even shorter treatment durations,” said the news service.

Bristol-Meyers faces stiff competition from major market leaders, most notably Gilead Sciences Inc, whose new hepatitis C blockbuster, Sovaldi, has quickly eaten up market share and shown cure rates around 90 percent in only three months.

Bristol-Meyers executives said Wednesday that the company will work with the FDA to provide the info requested.

“Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area,” said Francis Cuss, executive vice president and chief scientific officer of research and development for Bristol-Myers Squibb. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible.”

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