PharmAust seeks European orphan drug designation for MND/ALS drug monepantel
PharmAust seeks European Medicines Agency's orphan medicinal product designation for monepantel (MPL) in treating ALS/MND, following a pre-submission meeting. The designation could offer incentives like protocol assistance and 10 years of market protection. PharmAust already received an orphan drug designation from the FDA in May, providing US incentives.
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PharmAust seeks European Medicines Agency's orphan medicinal product designation for monepantel (MPL) in treating ALS/MND, following a pre-submission meeting. The designation could offer incentives like protocol assistance and 10 years of market protection. PharmAust already received an orphan drug designation from the FDA in May, providing US incentives.
PharmAust submits OMPD request to EMA for monepantel to treat ALS, following pre-submission meeting. The company already received ODD from FDA for the same drug. OMPD offers regulatory and commercial incentives, including 10 years market exclusivity and reduced fees.