Clinical Trial: Mycapssa (octreotide capsules) for Neuroendocrine Tumours
The delayed-release capsules contain 20mg of octreotide. Update 20th Dec 2022The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for orphan designation for the use of Mycapssa® in the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET).Orphan designation in the European Union (EU) is granted by the European Commission (EC) within 30 days of a positive opinion being issued by the COMP. This designation provides certain regulatory and financial incentives including but not limited to product market exclusivity for ten years in the EU following regulatory approval. THIS IS NOT AN APPROVAL but it moves this one step closer. Update 14th July 2022. Amryt Receives Orphan Drug Designation from the FDA for Mycapssa® (oral octreotide) for the Treatment of Carcinoid Syndrome. The details of Phase 3 clinical…
