Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has issued a complete response letter for
ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor,
for once-daily (QD) use in the treatment of certain types of
myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host
disease (GVHD).
The complete response letter states that the FDA cannot approve
the application in its present form. The FDA acknowledged that the
study submitted in the New Drug Application (NDA) met its objective
of bioequivalence based on area under the curve (AUC) parameters
but identified additional requirements for approval. Incyte intends
to meet with the FDA to determine appropriate next steps.
“While we are disappointed that the FDA issued a complete
response letter for ruxolitinib extended-release tablets, we remain
committed to advancing care for people with myeloproliferative
neoplasms and GVHD,” said Hervé Hoppenot, Chief Executive Officer,
Incyte. “We will work closely with the FDA on the appropriate next
steps to address their comments.”
The NDA was based on two studies designed to show that
ruxolitinib XR tablets are dosage strength proportional and
bioequivalent to Jakafi® (ruxolitinib) tablets. The first study was
designed to determine the relative bioavailability of ruxolitinib
XR tablets to Jakafi tablets and to demonstrate that ruxolitinib XR
tablets are dosage strength proportional to Jakafi tablets. The
second study was an open-label, randomized, two-period, two-way
crossover study in 63 healthy adults evaluating the bioequivalence
of the highest strength of ruxolitinib XR tablets (50 mg) dosed
once-daily (QD) to the highest strength of Jakafi tablets (25 mg)
dosed twice-daily (BID), following a single dose and at
steady-state. Study results demonstrated that ruxolitinib XR 50 mg
tablets dosed QD is bioequivalent to Jakafi 25 mg tablets dosed
BID, based on AUC parameters.
About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a
JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of
polycythemia vera (PV) in adults who have had an inadequate
response to or are intolerant of hydroxyurea; intermediate or
high-risk myelofibrosis (MF), including primary MF,
post-polycythemia vera MF and post-essential thrombocythemia MF in
adults; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older1.
Jakafi is a registered trademark of Incyte.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause low
platelet, red blood cell, and white blood cell counts. If you
develop bleeding, stop taking Jakafi and call your healthcare
provider. Your healthcare provider will do a blood test 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.
Cancer: Some people have had certain types of
non-melanoma skin cancers during treatment with Jakafi. Your
healthcare provider will regularly check your skin during your
treatment with Jakafi. Tell your healthcare provider if you develop
any new or changing skin lesions during treatment with Jakafi.
Increases in cholesterol: You may have changes in your
blood cholesterol levels during treatment with Jakafi. Your
healthcare provider will do blood tests to check your cholesterol
levels about every 8 to 12 weeks after you start taking Jakafi, and
as needed.
Increased risk of major cardiovascular events such as heart
attack, stroke or death in people who have cardiovascular risk
factors and who are current or past smokers while using another JAK
inhibitor to treat rheumatoid arthritis: Get emergency help
right away if you have any symptoms of a heart attack or stroke
while taking Jakafi, including: discomfort in the center of your
chest that lasts for more than a few minutes, or that goes away and
comes back, severe tightness, pain, pressure, or heaviness in your
chest, throat, neck, or jaw, pain or discomfort in your arms, back,
neck, jaw, or stomach, shortness of breath with or without chest
discomfort, breaking out in a cold sweat, nausea or vomiting,
feeling lightheaded, weakness in one part or on one side of your
body, slurred speech
Increased risk of blood clots: Blood clots in the veins
of your legs (deep vein thrombosis, DVT) or lungs (pulmonary
embolism, PE) have happened in people taking another JAK inhibitor
for rheumatoid arthritis and may be life-threatening. Tell your
healthcare provider right away if you have any signs and symptoms
of blood clots during treatment with Jakafi, including: swelling,
pain, or tenderness in one or both legs, sudden, unexplained chest
or upper back pain, shortness of breath or difficulty breathing
Possible increased risk of new (secondary) cancers:
People who take another JAK inhibitor for rheumatoid arthritis have
an increased risk of new (secondary) cancers, including lymphoma
and other cancers. People who smoke or who smoked in the past have
an added risk of new cancers.
The most common side effects of Jakafi include: for
certain types of myelofibrosis (MF) and polycythemia vera (PV) –
low platelet or red blood cell counts, bruising, dizziness,
headache, and diarrhea; for acute GVHD – low platelet counts, low
red or white blood cell counts, infections, and swelling; and for
chronic GVHD – low red blood cell or platelet counts and infections
including viral infections.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Call your
doctor for medical advice about side effects.
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 low white or red blood cell counts,
have or had tuberculosis (TB) or have been in close contact with
someone who has TB, had shingles (herpes zoster), have or had
hepatitis B, have or had liver or kidney problems, are on dialysis,
have high cholesterol or triglycerides, had cancer, are a current
or past smoker, had a blood clot, heart attack, other heart
problems or stroke, or have any other medical condition. Take
Jakafi exactly as your healthcare provider tells you. Do not change
your dose or stop taking Jakafi without first talking to your
healthcare provider.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breastfeed during treatment with Jakafi and
for 2 weeks after the final dose.
Please see the Full Prescribing Information,
which includes a more complete discussion of the risks associated
with Jakafi.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
You may also report side effects to Incyte Medical Information
at 1-855-463-3463.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
Forward-Looking Statements Except for the historical
information set forth herein, the matters set forth in this press
release, including statements regarding whether and when
ruxolitinib XR might provide a successful treatment option for
patients with myelofibrosis, polycythemia vera and
graft-versus-host disease, contain predictions, estimates and other
forward-looking statements.
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: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte and its partners’ clinical trials, supply chain,
other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of Incyte and its partners’ products; the acceptance of
Incyte and its partners’ products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report for the year ending December 31, 2022.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
1 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S.
Food and Drug Administration.
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version on businesswire.com: https://www.businesswire.com/news/home/20230323005785/en/
Media Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com
Kristen Griffiths +1 302 498 7012
kgriffiths@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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