FDA Grants Breakthrough Therapy Designation for Incyte’s Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease (GVHD)

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.
About Incyte
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.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Forward-Looking Statements
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.