Research & Development
The European Medicines Agency validates Roche's Marketing Authorisation Application for Satralizumab
1 November 2019 -

The European Medicines Agency (EMA) has validated Switzerland-based Roche's Marketing Authorisation Application for Satralizumab intended for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD) and grtanted it Accelerated Assessment, it was reported yesterday.

This move confirms that the submission is complete and indicates that the Marketing Authorisation Application (MAA) is under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).

The United States Food and Drug Administration (FDA) has also accepted the firm's Biologics License Application for satralizumab. The CHMP recommendation and the US FDA's decision are expected in 2020.

Accelerated Assessment decreases the timeframe for the EMA and CHMP to review the marketing authorisation, indicating that the treatment is of major interest for public health or therapeutic innovation. The US FDA granted Breakthrough Therapy Designation to satralizumab for the treatment of NMOSD in December 2018. In addition, the product has been granted Priority Review in Canada and Switzerland, and designated as an orphan drug in the United States, Europe and Japan.



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