BRIEF—EC green light for new subcutaneous Tysabri for MS

The European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of US biotech firm Biogen’s 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, according to Biogen.

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.