The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis - Seite 2

The EC’s approval of the SC route of administration for TYSABRI is based on data from the DELIVER and REFINE studies, which showed comparability to the Q4W IV administration of 300mg TYSABRI in efficacy, pharmacokinetic and pharmacodynamic profiles. Overall, the safety of TYSABRI SC in both studies was generally consistent with the well-established benefit-risk profile of TYSABRI IV in other clinical studies and the post-marketing setting, with the exception of injection site pain which can occur with SC injections.^3,4
  
“TYSABRI is a trusted high-efficacy therapy with a well characterized safety profile for patients living with MS. Nearly 15 years of real-world experience helps reinforce its effectiveness in reducing MS disease activity, showing that early treatment leads to better clinical outcomes,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “With chronic conditions like MS, we must continue to pursue innovations that can help patients better integrate their treatment preferences into their lives. This approval reflects our commitment to explore new possibilities with TYSABRI and meet the evolving needs of people living with MS.”

Approved by the EC in 2006, TYSABRI’s efficacy and safety have been shown through clinical trials and extensive real-world evidence gathered over nearly 15 years. During that time, Biogen has initiated research, through efforts such as the MS PATHS network and TYSABRI Observational program (TOP), that have broadened the clinical data for TYSABRI providing physicians and patients with more information on this established high-efficacy MS therapy with a well-characterized safety profile.

About TYSABRI (natalizumab)
TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. In the European Union, it is indicated as a single disease modifying treatment (DMT) in adults with highly active relapsing-remitting MS (RRMS) for patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. In the U.S., TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. TYSABRI is approved in 80 countries, and approximately 213,000 people worldwide have been treated with TYSABRI, with over 835,000 patient-years of experience, based on clinical trials and prescription data.⁵