The 24 May is the new Prescription Drug User Fee Act (PDUFA) target action date for Jakafi, which is the treatment for patients with GVHD who have had an inadequate response to corticosteroids.
The FDA has extended the action date to enable time to assess additional data provided by Incyte in reply to the FDA’s information requests.
The FDA has determined that submitted additional information need to constitute a major amendment to the sNDA, enabling to extend PDUFA goal date by three months.
In August 2018, Incyte submitted sNDA for ruxolitinib to treat patients with acute GVHD. Ruxolitinib secured priority review and breakthrough therapy designation from the FDA.
Ruxolitinib also secured orphan drug designation from the FDA for the treatment of GVHD.
GVHD is a condition that may result after an allogeneic stem cell transplant, where the donated cells begin an immune response and attack the transplant recipients organs. It will lead to significant morbidity and mortality.
GVH can occur in two forms such as acute and chronic, which can affect multiple organ systems such as skin, gastrointestinal (digestive) tract and liver.
Jakafi is a first-in-class JAK1/JAK2 inhibitor secured FDA approval to treat people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi can also be used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Incyte markets Jakafi in the US, while Novartis as Jakavi outside the US. In addition, ruxolitinib is being assessed in patients with acute and chronic GVHD who have an inadequate response to corticosteroids in the REACH2 and REACH3 clinical studies.
Incyte chief medical officer Dr Steven Stein said: “We remain confident in the data supporting our sNDA submission and look forward to continued dialogue with the FDA throughout the review process.
“We are committed to bringing ruxolitinib forward as a treatment option for patients with acute GVHD.”