FDA rescinds breakthrough therapy designation for daclatasvir

The FDA has rescinded breakthrough therapy designation status from Bristol-Myers Squibb for daclatasvir for the treatment of hepatitis C virus infection, according to a statement from the manufacturer.

“The FDA has informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the breakthrough therapy designation for certain genotype 1 hepatitis C regimens related to daclatasvir,” the statement from Bristol-Myers Squibb said. “This will not impact our current submission/resubmission timetable of the new drug application for daclatasvir in combination with other antiviral agents for the treatment of hepatitis C.”

Daclatasvir (Bristol-Myers Squibb) was granted breakthrough therapy designation in early 2014 as part of a dual investigational regimen with asunaprevir (Bristol-Myers Squibb) for chronic HCV. BMS withdrew its application for asunaprevir from the FDA in October 2014.  


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