EMA Recommends Approval for Eight New Drugs, One Biosimilar

The European Medicines Agency (EMA) announced on June 23, 2017 that its Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for marketing authorization. One of the recommendations included the biosimilar Imraldi (adalimumab), for the treatment of several forms of arthritis, Crohn’s disease, ulcerative colitis, and uveitis.

The other recommended medicines include cancer medications Kisqali (ribociclib), for the treatment of advanced or metastatic breast cancer; Fotivda (tivozanib), for the treatment of advanced renal cell carcinoma; and two drugs reviewed under the European Union’s accelerated assessment mechanism: Maviret (glecaprevir/pibrentasvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection.

CHMP gave a positive opinion to Mavenclad (cladribine) for the treatment of relapsing forms of multiple sclerosis and to generic drugs Efavirenz, Emtricitabine, and Tenofovir disoproxil Mylan (efavirenz, emtricitabine, tenofovir disoproxil) for the treatment of HIV infection and Nitisinone MendeliKABS (nitisinone) for the treatment of hereditary tyrosinemia type 1.

The committee recommended extensions of indications for Faslodex, Harvoni, Kaletra, Mimpara, Orencia, Soliris, SonoVue, Stivarga, and Victoza. It also concluded its review of Symbioflor 2 and decided the drug can continue to be used for the treatment of irritable bowel syndrome in adults but should no longer be used more widely to treat functional gastrointestinal disorders.

Source: EMA