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Amryt has set out its future plans to the investment community with much depending on the successful relaunch of its just-acquired acromegaly drug Mycapssa and a potential FDA approval for its epidermolysis bullosa gel Filsuvez.
No drugs are approved for epidermolysis bullosa and children with so-called butterfly skin are currently treated by cleaning open wounds and bandaging them. This could soon change.
The Irish drugmaker will have three approved commercial products for rare diseases – Mycapssa, Lojuxta and Myalept – with a potential fourth therapy on the way now Filsuvez has been filed for butterfly skin.
Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.