The FDA asked the company to submit additional confirmatory evidence of effectiveness in the treatment of epidermolysis bullosa.
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Amryt in regards to the New Drug Application (NDA) for Oleogel-S10 for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
A rare, genetic skin disease, epidermolysis bullosa is characterized by extremely fragile skin that blisters and tears from minor friction or trauma, with no currently approved treatment options. The Oleogel-S10 therapy is a topical gel to treat skin wounds in patients with the skin condition.
“We are extremely disappointed by this decision and we remain committed to our goal of bringing Oleogel-S10 to patients,” said Dr. Joe Wiley, CEO of Amyrt. “EB is a devastating disease with no approved treatment options and the EB community is desperate for a therapy.”
The FDA noted in its review that the application could not be approved in its present form, asking the company to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in epidermolysis bullosa treatment.
In the press release, Amryrt noted they intend to discuss with the FDA the nature of the data required to address the Agency’s concerns.
“We are committed to working collaboratively with the FDA to identify the most expeditious pathway towards a potential approval for this important therapy,” Wiley said.
The phase 3 EASE trial was the first randomized clinical trial ever conducted for epidermolysis bullosa and first phase 3 study to meet its primary endpoint of time to first target wound closure.
The therapy was reviewed on the FDA priority review track with an original expected Prescription Drug User Fee Act (PDUFA) decision date in November 2021.