The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI® (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis
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.”
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
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 increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), a decrease in lymphocyte counts and infections, including opportunistic and other atypical infections.
For information on TYSABRI prescribing information in the EU, please visit: https://ec.europa.eu/health/documents/community-register/html/h346.htm. Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website.
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