PharmAust (ASX:PAA) says it has completed a pre-submission meeting with the European Medicines Agency (EMA) and the Committee for Orphan Medicinal Products (COMP) and has submitted a request for orphan designation for monepantel for the treatment of amyotrophic lateral sclerosis (ALS).
The company said a decision is expected in December 2024. It said the request was made following the pre-submission meeting held in August 2024.
PharmAust has already received an orphan designation US FDA for the use of monepantel for ALS.
PharmAust managing director Dr Michael Thurn said, “We are encouraged by the feedback received by the EMA on our draft application and invitation to submit a full OPMD application. The evaluation period has a fixed duration of 90 days during which the COMP will consider our application, assessing clinical data alongside other evidence to determine the eligibility of MPL for OMPD."
The EMA's orphan designation provides structured regulatory and commercial incentives to companies.