In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has re­ject­ed In­cyte’s ex­tend­ed-re­lease for­mu­la­tion of rux­oli­tinib tablets, in a sur­prise set­back for the com­pa­ny’s plans to build on its block­buster Jakafi fran­chise.

The rux­oli­tinib XR tablets are de­signed to be tak­en once a day, where­as Jakafi is in­di­cat­ed for twice dai­ly dosage (al­though some pa­tients can take it once dai­ly).

Ac­cord­ing to In­cyte, the FDA ac­knowl­edged in its com­plete re­sponse let­ter that the study sub­mit­ted in the NDA “met its ob­jec­tive of bioe­quiv­a­lence based on area un­der the curve (AUC) pa­ra­me­ters but iden­ti­fied ad­di­tion­al re­quire­ments for ap­proval.”

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