“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.