Roche: rare disease drug accepted for review in US, Europe
(CercleFinance.com) - Roche moved a step closer to getting its experimental drug satralizumab approved in the United States and Europe after the FDA and the EMA accepted the medicine for review.
The European Medicines Agency (EMA) has validated the company's marketing authorisation application for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment.
In the US, the Food and Drug Administration (FDA) has also accepted the company's biologics license application (BLA) for satralizumab.
The CHMP recommendation and the FDA decision are expected in 2020, Roche said.
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The European Medicines Agency (EMA) has validated the company's marketing authorisation application for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment.
In the US, the Food and Drug Administration (FDA) has also accepted the company's biologics license application (BLA) for satralizumab.
The CHMP recommendation and the FDA decision are expected in 2020, Roche said.
Copyright (c) 2019 CercleFinance.com. All rights reserved.