CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly.-Amryt.

Amryt is pleased to announce that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Mycapssa in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.

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. Based on this CHMP recommendation a decision by the European Commission (EC) is expected on the Mycapssa application within 67 days. The centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The CHMP positive opinion is supported by efficacy and safety data from three Phase III studies in acromegaly patients including the pivotal MPOWERED Phase III trial.