EU approves SC version of Tysabri for multiple sclerosis.- Biogen

Biogen 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.