- U.S. regulators have accepted Bristol-Myers Squibb Co's re-submitted
marketing application for an experimental hepatitis C treatment after
the drugmaker was forced last year to withdraw its initial request.
Bristol-Myers on Thursday said
the U.S. Food and Drug Administration will review daclatasvir, its
so-called NS5A inhibitor, for use in combination with Gilead Sciences
Inc's potent and widely used Sovaldi treatment. It said the FDA is
expected to make its decision within six months.
originally had sought FDA permission to market daclatasvir in
combination with another Bristol drug, asunaprevir. But it abandoned
that application due to potential competition from more potent drugs,
leaving the FDA without data to gauge the effectiveness of daclatasvir
as part of a combination regimen.
Labels: BMS, daclatasvir, marketing application