Incyte Corporation (Nasdaq: INCY) announced today that Novartis received
approval from the European Commission for Jakavi®
(ruxolitinib) for the treatment of adult patients with polycythemia vera
(PV) who are resistant to or intolerant of hydroxyurea. Jakavi is the
first targeted treatment approved by the European Commission for these
patients.
Under the Incyte-Novartis Collaboration and License Agreement signed in
2009, Novartis received exclusive development and commercialization
rights to ruxolitinib outside of the United States for all hematologic
and oncologic indications, and sells ruxolitinib under the name Jakavi.
Ruxolitinib is marketed by Incyte in the United States as Jakafi®
(ruxolitinib). Jakafi® is approved by the U.S. Food and Drug
Administration for treatment of people with polycythemia vera 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.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi 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 experience unusual bleeding, bruising, fatigue, 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.
The most common side effects of Jakafi include: anemia, low
platelet count, 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 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.
Please see the Full Prescribing Information available at www.jakafi.com,
which includes a more complete discussion of the risks associated with
Jakafi.
Copyright Business Wire 2015