Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and
Drug Administration (FDA) has accepted for filing the supplemental New
Drug Application (sNDA) for ruxolitinib as a potential treatment of
patients with polycythemia vera (PV) who have had an inadequate response
to or are intolerant of hydroxyurea. The sNDA includes results from the
RESPONSE Phase III trial, which were recently presented at the 2014
American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE
was conducted under a Special Protocol Assessment (SPA) from the FDA.
The Prescription Drug User Fee Act (PDUFA) date for the sNDA for
ruxolitinib is set for December 5, 2014.
“We are pleased to have received the acceptance of our sNDA filing by
the FDA, and we believe that the submission contains a robust data set,”
stated Richard Levy, M.D., Executive Vice President and Chief Drug
Development and Medical Officer of Incyte. “We look forward to working
with the FDA to complete its review of this application”.
PV is a form of blood cancer leading to the overproduction of normal red
blood cells, white blood cells and platelets. Patients with uncontrolled
PV have an increased risk of cardiovascular complications such as
stroke, pulmonary embolism, deep vein thrombosis and heart attack.
Jakafi is the first and only FDA-approved treatment for patients with
intermediate or high-risk myelofibrosis (MF), including primary MF,
post–polycythemia vera MF and post–essential thrombocythemia MF.
Ruxolitinib is also the first JAK1/JAK2 inhibitor to demonstrate
efficacy in a Phase III trial in patients with polycythemia vera and, if
approved, would be the first JAK1/JAK2 inhibitor made available to
patients with polycythemia vera in the U.S.
About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN)
characterized by an overproduction of normal red blood cells, white
blood cells and platelets that leads to an increased risk of thrombosis.1-4
Erythrocytosis (elevated red blood cell mass) is the most prominent
clinical manifestation of PV, distinguishing it from other MPNs.5
PV may occur at any age but often presents later in life, with a median
age at diagnosis of 60 years.6,7 Approximately 100,000
patients in the United States are living with PV8 and
approximately 25 percent of patients with PV develop resistance to or
intolerance of hydroxyurea9,10 and are considered
uncontrolled.
About Jakafi® (ruxolitinib)
Jakafi is a prescription medicine approved by the U.S. Food and Drug
Administration to treat 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 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
while taking Jakafi. Tell your healthcare provider if you develop
symptoms such as chills, nausea, vomiting, aches, weakness, fever, or
painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache.
These are not all the possible side effects of Jakafi. Ask your
healthcare provider or pharmacist 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
liver or kidney problems, are on dialysis, 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.incyte.com,
which includes a more complete discussion of the risks associated with
Jakafi.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary small molecule drugs, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation statements
with respect to the potential efficacy, safety and therapeutic value of
ruxolitinib in polycythemia vera, including the potential for
ruxolitinib to become the first JAK1/JAK2 inhibitor available for
patients with polycythemia vera in the U.S., and working with the FDA to
complete its review of the supplemental New Drug Application, contain
predictions and estimates and are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. 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, 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, competitive and technological
advances, and other risks detailed from time to time in Incyte's filings
with the Securities and Exchange Commission, including its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2014. Incyte
disclaims any intent or obligation to update these forward-looking
statements.
References
1. Vannucchi AM, Guglielmelli P, Tefferi A. CA Cancer J Clin. 2009;59:171-91.
2. Marchioli R, Finazzi G, Specchia G, et al. N Engl J Med. 2013;368:22-33.
3. Tefferi A. Am J Hematol. 2013;88:507-16.
4. Spivak JL. Blood. 2002;100:4272-90.
5. Spivak JL. Ann Intern Med. 2010;152:300-6.
6. Tefferi A, Rumi E, Finazzi G, et al. Leukemia. 2013;27:1874-81.
7. Gruppo Italiano Studio Policitemia. Ann Intern Med. 1995;123:656-64.
8. Data on file. Incyte Corporation
9. Barosi G, Birgegard G, Finazzi G, et al. Br J Haematol.
2010;149:961-3.
10. Alvarez-Larrán A, Pereira A, Cervantes F, et al. Blood.
2012;119:1363-9
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