Posted by Michael Wonder on 17 Aug 2020
PTC announces the acceptance of the European marketing authorisation application for Evrysdi (risdiplam) for the treatment of spinal muscular atrophy
17 August 2020 - Marketing authorisation application based on data from multiple pivotal trials in infants, children and adult patients with spinal muscular atrophy.
PTC Therapeutics today announced the acceptance of the marketing authorisation application by the EMA for Evrysdi (risdiplam) for the treatment of spinal muscular atrophy.
The EMA previously granted PRIME (PRIority MEdicines) designation to risdiplam for the treatment of people with spinal muscular atrophy, providing a pathway for accelerated evaluation by the agency.
The milestone triggers a $15 million payment to PTC Therapeutics from Roche.
