The application incorporates all indications covered by the reference medicine, Biogen’s Tysabri (natalizumab), for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults and Crohn’s disease.
A marketing authorisation application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active RRMS.
