More New EU Drug Approvals Bring Total For Year To 14
Seven new drugs were approved in the EU in the March-April period this year: TiGenix/Takeda's Alofisel, BioCryst's Alpivab, Chiesi's Lamzede, AstraZeneca's Lokelma, Pfizer's Mylotarg, GSK's Shingrix and MSD's Steglatro.
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TiGenix says its treatment for complex perianal fistulae in Crohn’s disease is the first allogeneic stem cell therapy to be approved under Europe’s centralized marketing authorization pathway.
Seven products containing a new active substance were approved in Europe in the first two months of 2018: Shire's Adynovi and Roche/Chugai's Hemlibra for hemophilia A, Roche's Ocrevus for multiple sclerosis, Kyowa Kirin's Crysvita for hypophosphatemia, AstraZeneca's Fasenra for asthma, Novo Nordisk's Ozempic for diabetes, and MSD's Prevymis for prophylaxis of cytomegalovirus infection.