EMA accelerated assessment for Roche's satralizumab application

The European Medicines Agency has validated the Marketing Authorization Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment, according to a statement from Swiss pharma giant Roche (ROG: SIX) this morning.

NMOSD is a rare relapsing autoimmune disorder that causes inflammation in the optic nerve and spinal cord.

Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The US Food and Drug Administration has also accepted the company’s Biologics License Application (BLA) for satralizumab. The CHMP recommendation and the FDA decision are expected in 2020.