FDA Accepts Biologics License Application For ZINBRYTA

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The FINANCIAL — On April 29 Biogen and AbbVie announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS).

“We are pleased by the FDA’s acceptance of our BLA for ZINBRYTA, which we believe has the potential to help people living with MS,” said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen. “We look forward to working with both U.S. and European regulatory authorities to bring this investigational treatment to MS patients as soon as possible.”

Biogen and AbbVie announced in March 2015 that their Marketing Authorisation Application for ZINBRYTA was validated by the European Medicines Agency for review in the European Union.

The BLA included results from two pivotal trials, DECIDE and SELECT, in which ZINBRYTA 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS, according to Biogen.

“This is an important milestone in the development program for ZINBRYTA and moves us a step closer to potentially bringing a new treatment option to patients with MS,” said Michael Severino, M.D., executive vice president, Research and Development and Chief Scientific Officer at AbbVie.


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