Amryt Gets FDA Orphan Designation for Mycapssa in Carcinoid Syndrome

By Colin Kellaher

Amryt Pharma PLC on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to Mycapssa for the treatment of carcinoid syndrome, the most common functional syndrome associated with neuroendocrine tumors.

The biopharmaceutical company said it plans to launch a Phase 3 study in patients with carcinoid syndrome in early 2023.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Mycapssa is already approved in the U.S. for long-term maintenance therapy in certain patients with acromegaly, a rare condition where the body produces too much growth hormone, causing body tissues and bones to grow more quickly.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

July 14, 2022 07:34 ET (11:34 GMT)

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