WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.
Breakthrough Therapy Designation is designed to expedite the development and review of drugs for serious or life-threatening conditions and to help ensure people have access to them through FDA approval as soon as possible. The criteria for awarding Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have clinically significant improvement over available therapy.
“Receiving Breakthrough Therapy Designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”
In March 2016, Incyte and Lilly agreed to amend their License, Development and Commercialization Agreement to enable Incyte to independently develop and commercialize ruxolitinib for GVHD. In April 2016, Incyte and Novartis also agreed to amend their Collaboration and License Agreement, granting Novartis the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S.
About Graft-Versus-Host Disease (GVHD)
Graft-versus-host disease (GVHD) is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue). In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. There are two forms of GVHD; acute and chronic. GVHD is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with GVHD.
About Jakafi® (ruxolitinib)
Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi® (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
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 Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States.
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.
Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
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Except for the historical information set forth herein, the matters set forth in this press release, including statements with respect to the Company’s plans and expectations for its GVHD development program, including the timing of the commencement of a registration study for ruxolitinib in GVHD, and the potential for ruxolitinib to assist GVHD patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of ruxolitinib or other compounds in the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2016. Incyte disclaims any intent or obligation to update these forward-looking statements.