Janssen Research & Development Release: INCIVO® Receives Positive Opinion From the Committee for Medicinal Products for Human Use (CHMP) for Twice Daily Dosing for Treatment of Genotype-1 Hepatitis C Virus
4/26/2013 10:08:08 AM
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BEERSE, Belgium, April 26, 2013 -- /PRNewswire/ --
- OPTIMIZE study results presented at EASL show similar sustained virological response (SVR12) rates in patients with fibrosis or cirrhosis receiving an INCIVO®(telaprevir) combination treatment twice daily versus every eight hours - Janssen Infectious Diseases-Diagnostics BVBA (Janssen), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of twice daily (BID) dosing of INCIVO® (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin (PR).
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