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Incyte Says FDA Extends Review Period For Ruxolitinib SNDA - Quick Facts

Biopharmaceutical company Incyte Corp. (INCY) announced Tuesday that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).

The Prescription Drug User Fee Act (PDUFA) target action date is now extended by three months to September 22, 2021 to allow time to review additional data submitted by Incyte in response to the FDA's information request.

The sNDA was based on data from REACH3, a Phase 3 randomized, open-label, multicenter study comparing ruxolitinib with best available therapy (BAT) in adult and pediatric patients 12 years and older with steroid-refractory chronic GVHD.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults.

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