Amryt Pharma receives positive COMP opinion on orphan designation for Mycapssa

Amryt announces that the European Medicines Agency’s Committee for Orphan Medicinal Products has adopted a positive opinion for orphan designation for the use of Mycapssa in the treatment of carcinoid syndrome associated with neuroendocrine tumors. The granting of the orphan designation in the treatment of carcinoid syndrome follows the COMP positive opinion in October 2022 recommending that the orphan designation of Mycapssa in the treatment of acromegaly in the EU is maintained following approval of the marketing authorisation for the product. The Committee for Medicinal Products for Human Use issued a positive opinion on September 16, 2022, recommending the approval of Mycapssa in the EU for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide, with the EC approval subsequently being granted on December 2, 2022.