Priority review voucher updates: Who's won PRVs, who's bought them, and how much they're selling for
Article updated 4/10/24 to note that Italfarmaco won a rare pediatric PRV for the approval of Duvyzat (givinostat) for the treatment of Duchenne Muscular Dystrophy in children six years of age and older. Orchard Therapeutics also recently won a PRV for the approval of its gene therapy Lenmeldy (atidarsagene autotemcel).
The FDA can award biopharma companies with priority review vouchers (PRVs) following new approvals of treatments for neglected tropical diseases, rare pediatric diseases and medical countermeasures. The system by which PRVs are sold, typically for around $100 million each, continues to thrive, more than a decade after it was created.
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