Incyte (Nasdaq: INCY) today announced that the United States 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 of age and older with chronic graft-versus-host disease (GVHD) refractory to steroids. The new target action date for the Prescription Drug User Fees Act (PDUFA) is September 22, 2021.
The FDA has extended the PDUFA action date to allow time to review additional data submitted by Incyte in response to the FDA’s request for information. The submission of the additional information has been determined by the FDA to constitute a major amendment to the sNDA, resulting in a three-month extension of the PDUFA deadline.
“We remain confident in the data from the REACH3 trial supporting our sNDA submission for ruxolitinib and look forward to continuing the dialogue with the FDA throughout the review process,” said Steven Stein MD, Medical Director of Incyte . “We will work closely with the agency and are committed to bringing this innovative treatment to patients with chronic steroid-refractory GVHD who urgently need new treatment options.”
The sNDA was based on data from REACH3, a randomized, open-label, multicenter phase 3 study comparing ruxolitinib with the best available treatment (BAT) in adult and pediatric patients 12 years of age and older with chronic steroid refractory GVHD.
About Jakafi® (ruxolitinib)
Jakafi is a US FDA-approved first JAK1 / JAK2 inhibitor for the treatment of polycythemia vera (PV) in adults who have had an inadequate response or are intolerant to hydroxyurea, myelofibrosis (MF) at intermediate or high risk. , including primary MF, postpolycythemia vera MF, and essential postthrombocythemia MF in adults, and for the treatment of acute steroid refractory GVHD in adult and pediatric patients 12 years of age and older.
Jakafi is marketed by Incyte in the United States and by Novartis under the name Jakavi® (ruxolitinib) outside the United States Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside of the United States
Incyte is a global biopharmaceutical company based in Wilmington, Delaware, focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary treatments. For more information on Incyte, please visit Incyte.com and follow @Incyte.
Except for historical information set forth herein, matters set forth in this press release, including statements regarding the Company’s ongoing clinical development program for ruxolitinib, the REACH program and the GVHD program of the Society in general, and if and when ruxolitinib will be approved for use in the United States or elsewhere for chronic steroid-refractory GVHD or any other indication, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including unforeseen developments and risks related to: unforeseen delays; the pursuit of research and development and the results of clinical trials which may be unsuccessful or insufficient to meet applicable regulatory standards or justify further development; the ability to enroll a sufficient number of subjects in clinical trials and the ability to enroll subjects according to scheduled schedules; the effects of the COVID-19 pandemic and pandemic response measures on clinical trials, the supply chain and other third party vendors as well as the Company’s development and discovery operations; decisions made by the FDA; the Company’s dependence on its relations with its collaborative partners; the effectiveness or safety of the Company’s products and the products of the Company’s collaborative partners; market acceptance of the Company’s products and the products of the Company’s collaborative partners; competition in the market; sales, marketing, manufacturing and distribution requirements; spending higher than forecast; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report on Form 10-Q for the quarter ended March 31, 2020. The Company disclaims any intention or obligation to update these gazing statements.
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