Biogen recently announced that Tysabri (natalizumab), a drug developed to treat people with multiple sclerosis (MS), received a positive opinion from the European Medicines Agency (EMA), recommending its approval as a therapy for patients with relapsing-remitting multiple sclerosis (RRMS) who have a highly active disease activity, despite treatment with at least one other disease modifying therapy (DMT).
Tysabri has already been approved as a DMT for MS in many places, including the U.S., the European Union, Canada, and Australia. The Committee of Medicinal Products for Human Use (CHMP) of EMA has now adopted changes to the existing use of Tysabri. The changes propose that the drug can be used in RRMS patients with high disease activity even when treated with at least one DMT.
“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 of Worldwide Medical at Biogen, in a press release. “This update to the European marketing authorization would allow patients with highly active disease to switch to Tysabri regardless of the prior DMT used.”
A 10-year prospective, real-world, open-label study called TOP (Tysabri Observational Program) generated data supporting Biogen’s application, and led to the positive opinion of the CHMP. According to the TOP study, Tysabri significantly reduces the activity of MS, and its benefit-risk profile is favorable, independently of which DMT was used previously by the patient. The results were presented at the 68th American Academy of Neurology (AAN) Annual Meeting, held in April in Vancouver, Canada.
A final decision from EMA regarding the new indication for Tysabri is expected within the next two months.
Tysabri is a monoclonal antibody that is thought to act as an anti-inflammatory. Although the exact mechanism of action is not very well understood, Tysabri has been proven to reduce the relapse rate in MS. Tysabri has also been shown to increase the risk of a rare opportunistic viral infection of the brain called progressive multifocal leukoencephalopathy (PML).
The use of the drug has been associated with some cases of severe disability and even death. However, the overall benefits of the drug still overweight the risks associated with it, according to Biogen.
MS is the most common disabling neurological condition worldwide, typically affecting young adults from the ages of 20 and 40. Around 85 percent of people with MS have RRMS.