Amryt Pharma submits a formal dispute resolution to the FDA over rejected skin disease drug
The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.
After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.
According to the company, it recently had a meeting with the FDA to discuss the issues raised in the February CRL. The biotech initially reported that the FDA demanded “additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.”
Following this meeting, Amryt said it plans to continue down the formal dispute resolution path through CDER by which NDA applicants can seek to resolve scientific or medical disputes “that cannot be resolved at the division level.”
“The Formal Dispute Resolution process provides an opportunity to raise our scientific disagreement within CDER. We believe this represents the right approach toward approval in the US for Oleogel-S10, as we work toward bringing this therapy to EB sufferers in desperate need,” said Amryt CEO Joe Wiley in a statement.
The news that Amryt is pushing back on the FDA comes on the heels of the European Commission approving the drug. The EMA said the benefit of Filsuvez is its ability to promote the healing of EB partial thickness wounds.
The news from the EMA and the continued actions against the FDA has been music to investors’ ears. The company’s stock price $AMYT has risen 7% in the past five days but is still down 37% since the beginning of 2022.
The drug itself has gone through an eventful ride. Originally picking up the drug from the small German drugmaker Birken, the candidate began showing progress. In 2020, Phase III data showed that across 223 patients, those who received the drug were more likely to see their wounds close within 45 days than those on placebo.
In 2021, the FDA granted priority review to the drug, accelerating the drug’s assessment time from 10 months to six months until running into the CRL this year.