Amryt announces the European Commission, EC, 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. The centralized marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The EC approval of Mycapssa is supported by efficacy and safety data from three Phase 3 studies in acromegaly patients including the pivotal MPOWERED Phase 3 trial. Dr Joe Wiley, CEO of Amryt Pharma, commented: "The EC approval of Mycapssa(R) is a significant development for acromegaly sufferers in Europe and Mycapssa will be the first and only oral somatostatin analog approved in the EU."
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