Big month for EMA/CHMP drug recommendations
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 new medicines, including two biosimilars, for approval at its September meeting.
The CHMP recommended granting marketing authorizations for two cancer medicines: Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, from US biotech firm Tesaro (Nasdaq: TSRO); and Tookad (padeliporfin), from Luxembourg-based Steba Biotech, for the treatment of adenocarcinoma of the prostate.
Two medicines for the treatment of adults with moderate to severe chronic obstructive pulmonary disease, both from UK pharma major GlaxoSmithKline (LSE: GSK), also received a positive opinion from the Committee: Elebrato Ellipta (fluticasone furoate/umeclidinium/vilanterol) and Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol).
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