Six medicines recommended for approval by EMA/CHMP
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, two of which were Orphan designated, for marketing authorization at its February 2016 meeting.
The CHMP recommended granting marketing authorizations for two drugs for the prevention and treatment of bleeding in patients with hemophilia B, Alprolix (eftrenonacog alfa), from Biogen (Nasdaq: BIIB) and Swedish Orphan Biovitrum (STO: SOBI), and Idelvion (albutrepenonacog alfa) from CSL Behring. Both these medicines have an orphan designation.
French drugmaker Servier’s Lonsurf (trifluridine/tipiracil) was recommended by the CHMP for the treatment of metastatic colorectal cancer.
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