The FINANCIAL — The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a variation to the marketing authorization of TYSABRI (natalizumab), Biogen announced on May 31.
The CHMP recommends the approval of TYSABRI for use as a disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT. The positive opinion is supported by long-term real-world experience from the TYSABRI Observational Program (TOP), an ongoing observational, open-label, 10-year prospective study of RRMS patients.
“For nearly 10 years, TYSABRI has provided patients and physicians with a high efficacy therapy that has a well-established tolerability and safety profile,” said Ralph Kern, senior vice president, Worldwide Medical. “This update to the European marketing authorization would allow patients with highly active disease to switch to TYSABRI regardless of the prior DMT used.”
Data Supporting Positive Opinion
The CHMP opinion is based on real-world data from the TOP study. Results from TOP, recently presented at the 68th American Academy of Neurology annual meeting, showed that TYSABRI significantly reduced multiple sclerosis disease activity and demonstrated a favorable benefit-risk profile, regardless of which prior DMT was used. The incidence of reported serious adverse events was consistent with TYSABRI’s known safety profile.
The opinion of the CHMP is now referred to the European Commission (EC) for final decision on approval.
This positive opinion follows April 2016 EC approvals that granted TYSABRI unlimited validity for the marketing authorization in Europe and updated the European Union product information and physician/patient education materials. The new patient management plan provides an updated risk algorithm which allows physicians to have more individualized benefit-risk discussions with their patients and provides them with clear guidelines to manage their patients appropriately.
According to the EMA, the updated risk estimates show that the risk of developing progressive multifocal leukoencephalopathy (PML) is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with TYSABRI for longer than two years. In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients. Biogen is committed to patient safety and continues to work closely with the scientific community to provide greater clarity on the minimization of risk for patients taking TYSABRI.
