On June 8, 2021 Incyte (Nasdaq:INCY) reported 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) (Press release, Incyte, JUN 8, 2021, View Source [SID1234584957]). The new Prescription Drug User Fee Act (PDUFA) target action date is September 22, 2021.
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The FDA extended the PDUFA action date to allow time to review additional data submitted by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.
"We remain confident in the data from the REACH3 trial supporting our sNDA submission for ruxolitinib and look forward to continued dialogue with the FDA throughout the remainder of the review process," said Steven Stein M.D., Chief Medical Officer, Incyte. "We will work closely with the agency and are dedicated to bringing this innovative treatment to patients with steroid-refractory chronic GVHD who urgently need new treatment options."
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.
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults, and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.