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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