FDA rejects oleogel-S10 NDA for epidermolysis bullosa
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The FDA has denied a New Drug Application for oleogel-S10 for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis bullosa, Amryt Pharma announced in a press release.
In a complete response letter, the FDA requested additional efficacy evidence for oleogel-S10.
The topical herbal medication contains birch triterpenes from birch bark, according to the company.
Epidermolysis bullosa (EB) is a group of hereditary disorders which result in extreme skin fragility and blister development, as well as scarring, ulcers and strictures of the esophagus and mucous membranes. Patients with EB also have a high risk of developing squamous cell carcinomas and infections.
“We are extremely disappointed by this decision, and we remain committed to our goal of bringing oleogel-S10 to patients. EB is a devastating disease with no approved treatment options and the EB community is desperate for a therapy,” Joe Wiley, MB, BAO, BCh, Amryt Pharma CEO, said in the release. “The EASE study was the largest randomized clinical trial ever conducted in this disease and the first Phase 3 study to meet its primary endpoint. We are committed to working collaboratively with the FDA to identify the most expeditious pathway towards a potential approval for this important therapy.”
The company plans to discuss additional data with the FDA to address the agency’s concerns.
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