EMA Recommends Ten Drugs for Approval

At the November 2017 meeting of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), 10 new medicines were recommended for approval. Among the approved drugs were two with orphan designation: Jorveza (budesonide), which treats eosinophilic esophagitis, and Prevymis (letermovir), an antiviral to prevent “cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic hematopoietic stem cell transplant.”

Other medicines that received marketing authorization approval included treatments for multiple sclerosis (Ocrevus), hemophilia A (Adynovi), eosinophilic asthma (Fasenra), and vulvar and vaginal atrophy (Intrarosa). Mvasi (bevacizumab), a biosimilar for the treatment of a variety of types of cancer, was also recommended for approval. Other generic drugs that were approved include HIV treatments Darunavir Krka (darunavir) and Darunavir Krka d.d. (darunavir) and breast cancer treatment Fulvestrant Mylan (fulvestrant).

CHMP also recommended extending the therapeutic indications for Adcetris, Genvoya, Nplate, and Orkambi. The committee’s review of Zinbryta (daclizumab), which treats multiple sclerosis, found that further restrictions were needed to reduce the risk of liver damage.