On 25 July, Prilenia shared that the application for pridopidine had been rejected for marketing authorisation in HD by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The application was based on post-hoc analyses from the EHDN-endorsed, Phase 3 PROOF-HD study, suggesting that the orally administered sigma-1 receptor agonist may offer potential benefits for a subset of people with HD who are not taking antidopaminergic medications. Prilenia and partner Ferrer are planning a further global study of pridopidine in HD, to confirm previously observed results.
For details of all ongoing and completed EHDN-endorsed studies, click here.