Incyte Announces U.S. FDA Has Extended the Review Period for Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease
“We remain confident in the data supporting our sNDA submission and look
forward to continued dialogue with the
The sNDA for ruxolitinib for the treatment of patients with acute GVHD
was submitted in
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipients organs, leading to significant morbidity and mortality. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including statements regarding whether or
when ruxolitinib might be approved in the U.S. for patients with acute
GVHD who have had an inadequate response to corticosteroids. These
forward-looking statements are based on Incyte’s current expectations
and subject to risks and uncertainties that may cause actual results to
differ materially, including unanticipated developments in and risks
related to the efficacy or safety of ruxolitinib for the treatment of
patients with acute GVHD who have had an inadequate response to
corticosteroids, the results of additional data and additional analyses
of data from the REACH1 study, actions taken by regulatory authorities,
and other risks detailed from time to time in Incyte’s reports filed
Michael Booth, DPhil