Ambitious Amryt To File Butterfly Skin Drug Imminently
Irish Firm Eyes 2021 Launches For Filsuvez
The Dublin-based drugmaker, powered by climbing revenues of Lojuxta and Myalept, is preparing its launch teams for Filsuvez, which has the potential to become the first treatment approved for epidermolysis bullosa and the company is banking on speedy regulatory reviews.
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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.
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.
In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.