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