In­cyte faces de­lay on FDA's Jakafi de­ci­sion for cGVHD; Bay­er's Parkin­son's cell ther­a­py en­ters the clin­ic

Just 10 months af­ter In­cyte post­ed an up­beat as­sess­ment for Jakafi in a Phase III for chron­ic graft-ver­sus-host dis­ease, the FDA has opt­ed to push back the sN­DA to lat­er in the year so it can ad­dress new da­ta sub­mit­ted for the sup­ple­men­tal ap­proval re­quest.

The new PDU­FA date has now slipped back to Sept. 22.

Ac­cord­ing to In­cyte, the agency pushed back the dead­line af­ter de­ter­min­ing that the added in­fo it had re­quest­ed added up to a ma­jor amend­ment to the ap­pli­ca­tion.

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