Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Ar­genx’s Vyv­gart is due for a speedy re­view at the FDA, thanks to a $102 mil­lion pri­or­i­ty re­view vouch­er (PRV).

The Nether­land-based biotech picked up the PRV from blue­bird bio, the com­pa­nies an­nounced on Wednes­day. PRVs short­en a drug’s FDA re­view pe­ri­od from 10 months to 6 months, though they of­ten sell on the open mar­ket for around $100 mil­lion each.

Ar­genx plans on us­ing the ex­press tick­et on ef­gar­tigi­mod, its neona­tal Fc re­cep­tor (FcRn) block­er mar­ket­ed as Vyv­gart for adults with gen­er­al­ized myas­the­nia gravis (gMG). While Vyv­gart won its first ap­proval last De­cem­ber for the chron­ic neu­ro­mus­cu­lar dis­ease — which is char­ac­ter­ized by dif­fi­cul­ties with fa­cial ex­pres­sion, speech, swal­low­ing and breath­ing — CEO Tim Van Hauw­er­meiren said in a news re­lease that he plans to “be ac­tive in fif­teen dis­ease tar­gets by 2025.”

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