US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA
Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.
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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.
Priced at a 50% premium to GW’s value, the deal will reduce the percentage of Jazz’s drug sales coming from Xyrem, provide double-digit revenue growth and expand the R&D pipeline to 19 programs.
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.