Jazz Phar­ma­ceu­ti­cals push­es to ex­pand la­bel on Xy­wav; FDA eyes Oc­to­ber for de­ci­sion on Seagen's lat­est ADC

Eight and a half months since its last OK for Xy­wav, Jazz Phar­ma­ceu­ti­cals has won pri­or­i­ty re­view for a new in­di­ca­tion with the drug.

The FDA grant­ed the ex­pe­dit­ed in­spec­tion Mon­day morn­ing, Jazz an­nounced, as the biotech looks to ex­pand Xy­wav in­to adult id­io­path­ic hy­per­som­nia pa­tients. Reg­u­la­tors have set a PDU­FA date of Aug. 12.

Back in Ju­ly 2020, Xy­wav notched its first ap­proval to treat cat­a­plexy and ex­ces­sive day­time sleepi­ness as­so­ci­at­ed with nar­colep­sy in pa­tients old­er than 7. At the time, the drug joined Sunosi and Xyrem in the com­pa­ny’s sleep­ing dis­or­der-re­lat­ed port­fo­lio.

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Cambridge, MA, USA