Four new medicines and three biosimilars recommended for approval in Europe

12 November 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines and three biosimilars for approval at its November meeting.

The CHMP recommended granting a marketing authorization for Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, from CSL Behring, a subsidiary of Australia’ CSL Limited (ASX: CSL). The drug was approved by theUS Food and Drug Administration in May this year.

Vemlidy (tenofovir alafenamide) received a positive opinion from the CHMP for the treatment of chronic hepatitis B from US biotech firm Gilead Sciences (Nasdaq: GILD). The recommendation comes just a day after the US FDA approved the drug for marketing.

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