European Commission Grants Marketing Authorisation for
MSD’s ZEPATIER™ (elbasvir/grazoprevir) for the Treatment of Chronic Hepatitis C
Infection
In Phase 3 Clinical Trials, ZEPATIER Achieved High
Cure (SVR) Rates Across Diverse Populations of Patients With Chronic
Hepatitis C, Including Those With Compensated Cirrhosis, Renal Impairment or on
Opioid Agonist Therapy
KENILWORTH, N.J., USA, July 29, 2016 – MSD
(tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) today
announced that the European Commission has approved ZEPATIER™
(elbasvir/grazoprevir) with or without ribavirin (RBV) for the treatment of
chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults. ZEPATIER
is MSD’s once-daily, fixed-dose combination tablet containing the NS5A
inhibitor elbasvir (50mg) and the NS3/4A protease inhibitor grazoprevir
(100mg). This approval allows marketing of ZEPATIER tablets in the 28
countries that are members of the European Union, as well as European Economic
Area members, Iceland, Liechtenstein and Norway. MSD continues to work to
supply the EU market, with product launches estimated to begin between the
fourth quarter of 2016 and the first quarter of 2017. Product launches are
expected to continue across the EU through 2017.
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