Amryt gets FDA orphan drug designation for Mycapssa for carcinoid syndrome


Amryt, a commercial-stage biopharma company, has secured orphan drug designation for Mycapssa (octreotide capsules) from the US Food and Drug Administration (FDA) for the treatment of carcinoid syndrome.

Carcinoid syndrome is the most common functional syndrome related to neuroendocrine tumors (NETs) that affects less than 200,000 people in the US.

Dr Joe Wiley — Amryt Pharma CEO said: “Today’s news is another significant milestone achieved in our plan to develop Mycapssa for patients affected by carcinoid syndrome associated with NET and we are excited at the potential for Mycapssa and our TPE technology to deliver an oral therapy option to NET patients in need.”

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Mycapssa has approval from the FDA for use as long-term maintenance therapy in patients having acromegaly who are responsive to and tolerated treatment with lanreotide or octreotide. The oral somatostatin analog has also been submitted to the European Medical Agency (EMA) and is yet to be approved in the European Union.

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