CHMP recommends several biologics

Two hepatitits C treatments got the EMA recommendation: Maviret (glecaprevir / pibrentasvir), a combination of inhibitors of the viral proteins NS3/4A and NS5A, from Abbvie and Vosevi (sofosbuvir / velpatasvir / voxilaprevir), a competitive nucleoside inhibitor of NS5B protein in combination with a NS5A and a NS3/4 virus protease blocker from Gilead Sciences.

The CHMP also recommended approval of Alexion Therapeutics’ targeted antibody therapy eculizumab in a subpopulation of patients with generalised myasthenia gravis overexpressing the Ach receptor. The antibody targets complement protein 5.

The EMA also recommended a novel treatment option for women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer: Novartis’ CDK4/6 blocker Kisqali (ribociclib) in combination with aromatase blocker standard therapy in first line setting.As a further cancer treatment, the committee greenlighted EUSA Pharma’s Fotivda (tivozanib) for patients with advanced for renal cell carcinoma, a treatment not approved by the FDA in 2013 because of a negative benefit/risk balance.

At the biosimilars front, Samsung Bioepis Co. Ltd. got a recommendation for its Humira biosimilar Imraldi in the same indications as Abbvie’s original TNF alpha blocker.

Finally, Merck KGaA Mavenclad (cladribine) tablets received a positive opinion for the treatment of relapsing forms of multiple sclerosis based on additional studies recommended by the EMA seven and six years ago, when Merck had withdrawn its MAA for the purine nucleoside analogon.