-Amryt Pharma said on Monday the U.S. Food and Drug Administration declined to approve the company's drug for the treatment of a group of rare skin diseases called epidermolysis bullosa.
The agency has asked Amryt to submit additional data confirming effectiveness of the drug.
The decision comes after the FDA had extended its review of the treatment, oleogel-S10, in November by three months to review additional analyses of data previously submitted by the company. The regulator had also asked for new information on the drug.
Amryt said it intends to discuss with the FDA regarding the nature of data required to address the health regulator's concerns.
Epidermolysis bullosa (EB) is a disease causing fragile skin that blisters and tears easily. Currently, there is no approved therapy for the condition. Treatment for EB has usually involved controlling symptoms by using and changing bandages as well as managing pain and itching with medications.
Oleogel-S10 is a topical gel containing birchbark extracts that speeds up healing of skin wounds in patients with dystrophic and junctional EB, two types of the disorder.
The European Medicines Agency is also reviewing oleogel-S10 for the treatment of junctional and dystrophic EB. The agency's panel of experts is expected to give its opinion on the treatment in March.