CHMP approves BMS' combo hep C therapy
- The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Daklinza (daclatasvir) in combination with other medications to treat different variants of chronic hepatitis C (HPV) in adults.
- The approval is based on trials that evaluated Daklinza in combination with sofosbuvir with or without ribavirin in patients with HCV genotypes 1, 2 or 3.
- Daklinza is a complex NS5A inhibitor—the first one to receive a positive opinion during CHMP review.
Daklinza was designed to address pan-genotypic HCV, thereby broadening treatment to include more patients than can be treated with sofosbuvir alone. Thus far, it has been used in 2,000 HCV special-access patients in Europe with advanced liver disease. Daklinza’s indication requires that it be used with other medications, and currently the main medication (based on trials) that has been used in combination with Daklinza is Gilead's sofosbuvir. However, BMS researchers are currently studying a three-in-one, fixed-dose medication that combines Daklinza with asunaprevir and BMS-791325. In 2013, this fixed-dose therapy received Breakthrough Therapy designation.