Amryt setback with CRL for Oleogel-S10 NDA from FDA

Shares of Ireland-headquartered rare diseased biotech Amryt Pharma (Nasdaq: AMYT) fell as much as 31% yesterday, after it announced the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Oleogel-S10, also known under the trade name Filsuvez, for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis bullosa (EB), a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma for which there are no approved treatment options. The stock partly recovered, ending the day down 14% at $6.98.

The FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the agency’s concerns.

Adds to FDA delay last year