Por: Portal Nacional de Seguros
New cure perspectives to some 4,5 milion of brazilians living with hepatitis C virus. MSD, announced this month that regulatory applications for boceprevir, MSD’s investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.
The U.S. Food and Drug Administration (FDA) granted the New Drug Application (NDA) for boceprevir Priority Review status, a designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. FDA’s goal for completing a Priority Review is six months.
Additionally, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for boceprevir for accelerated assessment. Accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest such as treatment of hepatitis C virus infection.
In Brazil, MSD intends to submit boceprevir to ANVISA (National Agency of Sanitarian Surveillance) at the first semester of this year.
About MSD
Merck, known as MSD outside the United States and Canada, its a global pharmaceutical company, result of a fusion that took place in 2009 between Merck Sharp & Dohme e a Schering-Plough.