Positive CHMP opinion for Janssen's simeprevir for chronic hepatitis C

24 March 2014

US health care giant Johnson & Johnson’s (NYSE: JNJ) European subsidiary Janssen R&D Ireland has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorization for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

Simeprevir is being developed by Janssen R&D Ireland under license from Sweden's Medivir (OMX: MVIR), which retains rights in the Nordic region.Simeprevir is a new generation, NS3/4A protease inhibitor administered as a once daily 150mg capsule with pegylated interferon (pegIFN) and ribavirin (RBV) offering proven efficacy across a range of different hepatitis C virus (HCV) patient types.

Sales forecasts

Simeprevir may generate $447 million for J&J in 2016, according to the average of four analysts’ estimates compiled by Bloomberg. The drug was approved for the treatment of genotype 1 HCV last September in Japan and in November in Canada and the USA under the trade name Olysio (The Pharma Letter November 25, 2013).

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