Five new meds, one biosimilar and two generics recommended for approval by EMA's CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines, a biosimilar and two generics for approval at its June meeting. The CHMP’s recommendations will be referred to the European Commission which is expected to make a final decision on the marketing authorisation application.

The CHMP recommended granting marketing authorizations for AbbVie’s (NYSE: ABBV) Maviret (glecaprevir/pibrentasvir) and Gilead Sciences’ (Nasdaq: GILD) Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection. Both medicines were reviewed under the EU’s accelerated assessment mechanism.

Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies. As this is considered to be of major public health interest in terms of therapeutic innovation, both medicines were evaluated under the EU’s accelerated assessment mechanism, which aims to speed up patients’ access to new medicines where there is an unmet medical need.