Biogen says European regulatory committee adopts positive view for Tysabri
pharmafile | June 1, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Biogen, CHMP, EMA, Tysabri, multiple sclerosis
Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its Tysabri (natalizumab) to treat relapsed multiple sclerosis.
The company said the Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the drug for use as a disease modifying therapy (DMT) in multiple sclerosis 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 therapy, the company said in a statement.
Ralph Kern, senior vice president, Worldwide Medical, said: “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.”
The opinion of the CHMP is now referred to the European Commission (EC) for final decision on approval.
Tysabri is a disease modifying therapy (DMT) approved in more than 80 countries including the US, the European Union, Canada, Australia and Switzerland.
Anjali Shukla
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