BMS scores "breakthrough" label for hep. C candidate
The race to develop an interferon-sparing treatment for hep. C continues to heat up. Despite a somewhat bland quarterly earnings statement Thursday, Bristol-Myers Squibb also announced that it had scored breakthrough treatment status from the FDA for its experimental hepatitis C NS5A drug daclatasvir in combination with an NS3 protease inhibitor, asunaprivir, and an NS5B non-nucleoside polymerase inhibitor, BMS-791325.
Those combinations may look familiar, because this same week, BMS reported mid-stage trial data where the three-drug combo boasted cure rates up to 94%. And earlier this week, the drug maker also said it was teaming up with Merck for Phase II testing that combined contributions from their respective labs (they're testing a combo regimen of BMS's daclatasvir with Merck's NS3/4A protease inhibitor MK-5172), but with no promises to necessarily go anywhere with the results once the data roll in. That announcement was equally explicit that the two companies were free to use their research with whomever they please.
In the case of BMS's three-drug experimental hep. C mix, it echoes the Merck alliance but with strictly home-grown tech.
FDA's breakthrough status designation is meant to help developers speed certain drugs to patients more quickly. The agency has pledged to work very closely with sponsors to determine how much data is needed for filing and how to scale up manufacturing, among other things.