Roche risdiplam application for spinal muscular atrophy accepted in Europe

Under PRIME status, the European Medicines Agency (EMA) has accepted for review Roche’s (OTCQX:RHHBY) marketing application seeking approval of Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA).

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

The action triggers a $15M milestone payment to licensor PTC Therapeutics (NASDAQ:PTCT).

The FDA approved the survival of motor neuron 2 splicing modifier on August 7.

https://seekingalpha.com/news/3606164-roche-risdiplam-application-for-spinal-muscular-atrophy-accepted-in-europe