Feb 4 (Reuters) - Merck & Co on Wednesday said the
U.S. Food and Drug Administration intends to rescind its
"breakthrough therapy" designation for the company's
experimental combination treatment for hepatitis C because of
other recently approved treatments.
Merck, in its fourth-quarter earnings report, said it plans
to discuss the matter with the FDA, and still expects to seek
U.S. approval for the treatment in the first half of 2015. It
consists of a protease inhibitor called MK-5172 and a so-called
NS5A inhibitor called MK-8742 that together had received the
"breakthrough therapy" designation from the FDA.
The setback for Merck's treatment follows recent approvals
of costly oral treatments for the liver disease from Gilead
Sciences Inc and AbbVie that have wiped out
all signs of the virus in more than 90 percent of patients after
eight or 12 weeks.
Labels: grazoprevir/elbasvir (MK-5172/MK-8742), Merck