Research & Development
US regulator extends review period for Incyte's supplemental new drug application for Jakafi
11 February 2019 -

The US Food and Drug Administration (FDA) has extended the review period for United States-based Incyte's supplemental new drug application (NDA) for acute graft-versus-host disease (GVHD) treatment, Jakafi (ruxolitinib), it was reported on Friday.

24 May is the new Prescription Drug User Fee Act (PDUFA) target action date for Jakafi, which is for the treatment of patients with GVHD who have had an inadequate response to corticosteroids. The FDA has extended the action date to allow time to evaluate additional data provided by the company in response to the regulator's information requests. It has determined that submitted additional information is required to constitute a major amendment to the supplemental NDA, enabling it to extend the PUDFA goal date by three months.

In August 2018, Incyte submitted a supplemental NDA for ruxolitinib intended to treat patients with acute GVHD. Ruxolitinib secured priority review and breakthrough therapy designation from the US FDA.