Amryt Pharma's hopes of getting a thumbs-up for Filsuvez by the end of the year have hit a bit of a bump with the news that US regulators have delayed a review of the Irish firm's butterfly skin therapy by three months.
The Dublin-headquartered group had a Prescription Drug User Fee Act target action date of 30 November for Filsuvez, which is also known as Oleogel-S10 and is in line to become the first treatment approved for epidermolysis bullosa (EB), a rare genetic condition where skin can tear at the slightest touch