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Biogen Gets Favorable View For TYSABRI Use In Highly Active RRMS


Biogen Inc (NASDAQ: BIIB) revealed Tuesday that the Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a favorable view for its TYSABRI (natalizumab). The regulator also recommended approval of a variation to the marketing authorization of the drug.

According to Biogen, the CHMP recommended 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 company added that a positive opinion was 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.

The company's SVP for Worldwide Medical, Ralph Kern, commented, "For nearly 10 years, TYSABRI has provided patients and physicians with a high efficacy therapy that has a well-established tolerability and safety profile. This update to the European marketing authorization would allow patients with highly active disease to switch to TYSABRI regardless of the prior DMT used."

Biogen said the favorable view came on the heels of April 2016 EC approvals granting TYSABRI unlimited validity for the marketing authorization in Europe and updated the European Union product information and physician/patient education materials. The company added that the new patient management plan offered an updated risk algorithm enabling physicians to have more individualized benefit-risk discussions with their patients and provided them with clear guidelines to manage their patients appropriately.

The company indicated that the latest CHMP opinion would now be referred to the European Commission (EC) for final decision on approval.

On Tuesday, the stock traded 1.15 percent higher.


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Posted-In: Biotech News FDA General

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