Amryt earns a priority review in a rare disease that makes patients' skin fragile as butterfly wings
A year after flashing mixed Phase III data, an Irish drugmaker notorious for owning some of the country’s most expensive drugs is getting an expedited look at its treatment for epidermolysis bullosa (EB) — a rare disease where a patient’s skin becomes as fragile as butterfly wings.
The FDA granted priority review to Amryt’s Oleogel-S10, accelerating the drug’s assessment time from 10 months to six months, the company said on Thursday. The agency set its PDUFA date for Nov. 30, and CEO Joe Wiley said launch plans are “well advanced.”
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