The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis

• TYSABRI is a well-established high-efficacy treatment that now provides two routes of administration enabling flexibility to meet patients' individual preferences and needs
• The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians beyond the infusion setting
• The approval adds to Biogen’s strong MS portfolio and is part of its leading, innovative work to improve the understanding of optimal clinical outcomes as part of the long-term treatment of patients with MS
  

CAMBRIDGE, Mass., April 07, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). The new route of administration offers comparable efficacy and safety to the TYSABRI intravenous (IV) formulation building on the therapy’s long-term data, established clinical benefits and well-characterized safety profile. TYSABRI is the only high-efficacy MS therapy to offer two routes of administration options providing patients and physicians the flexibility to choose the one that best fits their individual needs.

The SC and IV formulations of TYSABRI are dosed 300 mg, every four weeks (Q4W) by a healthcare provider. The SC option expands the clinical settings, beyond infusion centers, where patients can be treated. In addition, the SC formulation is administered in a shorter timeframe compared to the IV formulation and allows physicians to reduce or remove the post-dose observation period for some patients after six doses as clinically appropriate. The addition of the SC administration also offers people living with MS another option at a time when they are being encouraged to discuss considerations around COVID-19 vaccination and their MS treatment with their physicians.^1,2

“The subcutaneous administration of TYSABRI expands choices when it comes to controlling MS disease activity,” said Sven G. Meuth, M.D., PhD, professor of Neurology and Director of the Clinic of Neurology at the University Hospital of Düsseldorf. “I believe the SC administration offers an opportunity to receive comparable efficacy and safety to the intravenous formulation with reduced administration time which may be meaningful for patients. For physicians, the SC administration offers the ability to prescribe and administer TYSABRI in their practice, providing more locations where patients can be treated.”