Posted by Michael Wonder on 07 Dec 2021
EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD
6 December 2021 - Olipudase alfa has been granted PRIority MEdicines (PRIME) designation in Europe, breakthrough therapy designation in the United States, and SAKIGAKE designation in Japan.
The EMA has accepted for review under an accelerated assessment procedure the marketing authorisation application for olipudase alfa, Sanofi’s investigational enzyme replacement therapy which is being evaluated for the treatment of acid sphingomyelinase deficiency.
