BI 201335 filed with EMA for Hepatitis C- Boehringer

Boehringer Ingelheim has filed for EU marketing approval of BI 201335 (faldaprevir) in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) Hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease. In response, the EMA has granted the application accelerated assessment.

The EMA Application is based on a programme with focus on the Phase III STARTVerso trial data. This shows that 73% and 72% of patients treated with 120mg/240mg of BI 201335 in combination with pegylated interferon and ribavirin (PegIFN/RBV), respectively, achieved SVR12. Additionally, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso4) showed that 74% of patients treated with a faldaprevir-based regimen had undetectable HCV at four weeks.