Amryt announced that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion, recommending that the orphan disease designation of Mycapssa® in the treatment of acromegaly in the European Union (EU) is maintained. This follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion granted 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. The positive opinion of the COMP was based on the conclusion of significant benefit of Mycapssa® over available treatments for acromegaly and qualifies Mycapssa® for a period of 10 years' market exclusivity in the EU for this indication.

Mycapssa® is already approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide. The COMP positive opinion is supported by efficacy and safety data from three Phase 3 studies in acromegaly patients including the pivotal MPOWERED Phase 3 trial.