The U.S. FDA has denied approval for Amryt Pharma’s topical gel for a group of rare skin diseases called epidermolysis bullosa and asked the company to provide additional information that shows the drug's effectiveness.
The rejection comes after the agency had already pushed back the review timeline of the gel, known as oleogel-S10. In November, UK-based Amryt announced the FDA was extending the review by three months to conduct additional reviews of previously submitted data.
“We are extremely disappointed by this decision, and we remain committed to our goal of bringing oleogel-S10 to patients,” said Joe Wiley, CEO of Amryt. “EB is a devastating disease with no approved treatment options and the EB community is desperate for a therapy.”
Oleogel-S10 is a topical gel that speeds up skin healing using birchbark extracts. It is intended for use in patients with dystrophic and junctional EB, two types of skin disorder. EB, also known as 'butterfly skin,' is a disease that causes the skin to be extremely fragile, blistering and tearing easily. Currently, there is no treatment on the market and most therapies are aimed at controlling symptoms such as pain and itching.
Despite the rejection, Amryt does not appear to be giving up. The company is committed to working with the FDA to find a pathway towards potential approval for the therapy. After conducting the largest randomized clinical trial for EB and having the first phase 3 study to meet its endpoint, Amryt is looking for alternate routes to get the gel to market, according to Wiley.
The drug is also up for approval by the European Medicines Agency. Following a slight delay of the drug’s review in January, an EMA panel of experts is expected to have a decision made by March 2022.
