Posted by Michael Wonder on 05 Sep 2024
Prilenia’s pridopidine for Huntington’s disease accepted for European marketing authorisation review
3 September 2024 - Prilenia Therapeutics announces the acceptance of its European marketing authorisation application for pridopidine (45 mg orally twice daily) for the treatment of adults with Huntington’s disease by the EMA.
Prilenia holds orphan drug designation for pridopidine in Huntington’s disease and amyotrophic lateral sclerosis in the US and EU. In addition, pridopidine has received fast track designation by the US FDA for the treatment of Huntington’s disease.
