Biogen Receives FDA Approval for Tysabri Subcutaneous Formulation for Multiple Sclerosis

Biogen today announced that the FDA has approved a subcutaneous (SC) formulation of Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis (MS). The SC formulation offers patients a more convenient administration option compared to the existing intravenous (IV) infusion. In the Phase 3 DELIVER trial, the SC formulation demonstrated comparable pharmacokinetics and efficacy to the IV formulation. The SC injection can be administered in approximately 1 minute compared to the 1-hour IV infusion. This approval expands the administration options for Tysabri, which has been a cornerstone of MS treatment for nearly two decades.