The agency has asked Amryt to submit additional data confirming effectiveness of the drug.
Amryt Pharma announced on Monday that the US Food and Drug Administration has declined to approve the company’s drug for the treatment of epidermolysis bullosa, a group of rare skin diseases. The agency has requested that Amryt submit additional data confirming the drug’s efficacy. The decision follows the FDA’s decision in November to extend its review of the treatment, oleogel-S10, by three months in order to review additional analyses of data previously submitted by the company. The regulator had also requested new information about the drug.
Amryt stated that it plans to meet with the FDA to discuss the type of data needed to address the health regulator’s concerns. Epidermolysis bullosa (EB) is a skin disorder that causes fragile skin that blisters and tears easily. There is currently no approved treatment for the condition. EB treatment has typically consisted of controlling symptoms with bandages and medications, as well as managing pain and itching. Oleogel-S10 is a topical gel containing birchbark extracts that helps patients with dystrophic and junctional EB, two types of the disorder, heal skin wounds faster. The European Medicines Agency is also looking into the use of oleogel-S10 to treat junctional and dystrophic EB. In March, the agency’s expert panel is expected to issue a recommendation on the treatment.