EMA’s CHMP Issues Eight Positive Opinions, Including Two Hep C Antiviral Combinations

The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis.

The EMA’s Committee for Medicinal Products for Human Use recommended granting marketing authorizations for AbbVie’s Maviret (glecaprevir/pibrentasvir) and Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) antiviral combinations for chronic hepatitis C infections. Both were granted accelerated review.

Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in patients who cannot use previously available therapies, the EMA said.

The CHMP also recommended Novartis’ Kisqali (ribociclib) for metastatic breast cancer and EUSA Pharma’s Fotivda (tivozanib) for renal cell carcinoma. Mavenclad (cladribine), developed by Merck KGaA, received a positive opinion for treating relapsing forms of multiple sclerosis.