The delays keep coming at Amryt Pharma. After seeing approval decision dates for its rare skin disorder drug slip on both sides of the Atlantic late last year, Amryt has now reported a further two-month delay to the European Medicines Agency’s (EMA’s) decision about Oleogel-S10.
The EMA validated Amryt’s application in March 2021 and kicked off its standard review timeline, which takes up to 210 days, excluding times when the agency stops the clock to gather more information. As of early November, Amryt expected to receive a decision late in the fourth quarter, but that target slipped to January before the month was out. Now, Amryt has revealed another delay.
With the January meeting of the EMA’s Committee for Medicinal Products for Human Use coming to an end without a decision on Oleogel-S10 in epidermolysis bullosa, Amryt has revealed the wait will carry on into the spring.
Amryt attributed the delay to the EMA’s wish to hear from external epidermolysis bullosa experts before issuing an opinion. The delay will give the EMA time to set up an ad hoc group made up of epidermolysis bullosa experts and patients who can offer input on the disease, which affects an estimated 1 in 50,000 live births and lacks approved treatments. Amryt now expects the EMA to issue an opinion in March.
The delay comes two months after the FDA pushed back the PDUFA date for Oleogel-S10. With the drug benefiting from priority review in the U.S., Amryt was on course to receive a FDA decision by the end of November. The FDA delayed the PDUFA date until Feb. 28 to buy time to review additional analyses.
Amryt is seeking approval on the strength of a phase 3 clinical trial which linked Oleogel-S10, a gel that contains triterpenes from birch bark, to improvements in time to first target wound closure. The clinical trial suffered delays, too, getting started later than planned and dragging on for longer than expected.