Medivir AB announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorization in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

 

“The recommendation is one additional step in the global strategy that our partner Janssen has for simeprevir, to offer a new and efficacious treatment option to the many hepatitis C patient groups suffering from this devastating disease” said Maris Hartmanis CEO, Medivir.

 

Simeprevir is a new generation, NS3/4A protease inhibitor administered as a once daily 150 mg capsule with pegylated interferon (PegIFN) and ribavirin (RBV) offering proven efficacy across a range of different HCV patient types.

 

The CHMP opinion was based on positive and consistent results from three pivotal Phase 3 studies in patients with GT1 HCV; QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients (who have relapsed after previous interferon-based therapy). QUEST-1 and QUEST-2 included 785 treatment-naïve patients with chronic HCV GT1 infection. PROMISE included 393 relapsed patients with chronic HCV GT1 infection. All three studies met their primary end points and demonstrated simeprevir in combination with PegIFN/RBV achieves superior cure rates when compared with PegIFN/RBV alone, in treatment naïve and relapsed patients.

 

Date: March 21, 2014

Source: Medivir