Hansa Biopharma Interim Report January–March 2019
MAA filing of IDEFIRIX (imlifidase) in Europe marks a milestone in Hansa’s evolution into a commercial stage biopharmaceutical companyJanuary – March 2019 Highlights · The European Medicines Agency (EMA) accepted Hansa’s Marketing Authorization Application (MAA) for review of IDEFIRIX (imlifidase). This acceptance marks the beginning of the regulatory review process for IDEFIRIX in the European Union (EU). IDEFIRIX has both EU Orphan Drug Designation and PRIority MEdicine (PRIME) designation. An opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) is expected within