By Colin Kellaher

Shares of Amryt Pharma PLC fell more than 30% on Monday after the biopharmaceutical company said the U.S. Food and Drug Administration turned away its application seeking approval of Oleogel-S10 for the treatment of a rare, genetic skin disease.

Amryt said the FDA issued a complete response letter, indicating that the agency won't approve the application in its current form.

Amryt, which was seeking approval of Oleogel-S10 for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis bullosa, said the FDA has asked for additional confirmatory evidence of the drug's effectiveness.

The company said it plans to hold talks with the FDA to discuss the nature of the data needed to address the agency's concerns.

There are currently no FDA-approved treatment options for epidermolysis bullosa, a rare group of hereditary disorders characterized by extremely fragile skin that blisters and tears from minor friction or trauma.

Amryt shares were down 31% at $5.65 in early trading Monday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 28, 2022 09:57 ET (14:57 GMT)

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