Amryt to Pursue Formal FDA Resolution for Oleogel-S10

By Colin Kellaher

Amryt Pharma PLC plans to pursue a formal dispute resolution with the U.S. Food and Drug Administration over the agency's rejection of the biopharmaceutical company's Oleogel-S10 for the treatment of a rare, genetic skin disease, Amryt said Friday.

Its decision follows a recent meeting with the FDA to discuss the issues raised in a February complete response letter relating to the application seeking approval of Oleogel-S10 for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis bullosa, the company said.

It now plans to proceed to the formal resolution pathway in the FDA's Center for Drug Evaluation and Research, which lets applicants seek to resolve scientific and/or medical disputes that can't be resolved at the division level, Amryt said.

Amryt earlier this week won European Commission approval for the drug, marketed as Filsuvez, after the FDA in February turned away Amryt's application, asking for additional confirmatory evidence of the drug's effectiveness.

The FDA rejection sent Amryt shares tumbling to a 52-week low of $5.61 on Feb. 28, but the stock has recovered most its losses since then and rose nearly 7.5% Thursday following the European approval, to close at $7.36.

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.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 24, 2022 07:39 ET (11:39 GMT)

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