FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EMA Recommended More Drugs for Marketing Authorizations in 2017

Jan. 31, 2018

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorizations for 92 drugs and biologics in 2017, an increase from 81 in 2016 but down from 93 in the previous year.

Of the 35 recommended drugs containing new active substances, 11 were for cancer treatments; five for neurology; four for infectious diseases and immunology/rheumatology/transplantation; and three for endocrinology.

Three products received conditional marketing authorizations subject to post-authorization data requirements: Natpar (parathyroid hormone) for treatment of chronic hypoparathyroidism; Crysvita (burosumab) for treatment of x-linked hypophosphatemia in children and adolescents; and Bavencio (avelumab) for treatment of metastatic Merkel cell carcinoma.

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