- Jakavi® (ruxolitinib) is the first JAK1/2 inhibitor available
for patients in Europe who previously had no approved therapies for
the treatment of steroid-refractory graft-versus-host disease
(GVHD)1,2
- In clinical trials, Jakavi demonstrated superiority versus best
available therapy in patients with steroid-refractory/dependent
acute and chronic GVHD, with overall response rates of 62% vs. 39%,
and 50% vs. 26% respectively2,3
- GVHD is a common and potentially life-threatening complication
that arises in approximately half of patients following allogeneic
stem cell transplants4
Incyte (Nasdaq:INCY) today announced the European Commission
(EC) has approved Jakavi® (ruxolitinib) for the treatment of
patients aged 12 years and older with acute or chronic GVHD who
have inadequate response to corticosteroids or other systemic
therapies. Ruxolitinib is marketed as Jakavi by Novartis in Europe
and as Jakafi® by Incyte in the United States.
“With the approval of this new indication for Jakavi, patients
in Europe with acute or chronic GVHD who do respond to first-line
steroid therapies have a new option that could redefine treatment
for their condition,” said Peter Langmuir, M.D., Group Vice
President, Oncology Targeted Therapies, Incyte. “Unfortunately,
many people who receive allogenic stem cell transplants experience
GVHD, and it is our hope that this Incyte-discovered medicine will
make a significant impact for this patient population.”
The approval of Jakavi follows the positive opinion granted in
March 2022 by the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA), based on the Phase 3
REACH2 and REACH3 clinical studies in which Jakavi demonstrated
superiority in overall response rate (ORR) compared to best
available therapy (BAT). Results of REACH2 showed 62% ORR with
Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated
a significantly improved ORR at week 24 (50% vs. 26%) with a higher
best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent
chronic GVHD patients2,3.
“Today, 30-60% of patients with GVHD do not respond to
first-line steroid treatment, underscoring the need for new
approaches to ensure long-term treatment goals are met,” said
Robert Zeiser, M.D., University Hospital Freiburg, Department of
Haematology, Oncology and Stem Cell Transplantation, Freiburg,
Germany and lead investigator of the REACH trials. “The approval of
Jakavi offers healthcare providers and patients with GVHD who
remain dependent on or refractory to steroids a new way to manage
this debilitating and life-threatening condition.”
GVHD occurs when donor cells see the recipient’s healthy cells
as foreign and attack them. Symptoms of GVHD can appear in the
skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs
and joints. Approximately 50% of allogeneic stem cell transplant
recipients will develop either acute or chronic GVHD. Both acute
and chronic GVHD can be fatal and until now both have lacked an
established standard of care for patients who do not adequately
respond to first-line steroid treatment1,4-9. Currently, there are
no other approved therapies for the treatment of GVHD after steroid
failures in Europe1,2.
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 older10.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
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.
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 Jakavi
might provide a successful treatment for patients with acute or
chronic graft-versus-host disease (GVHD), the Company’s ongoing
clinical development program for ruxolitinib, the REACH program and
the Company’s GVHD program generally 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 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 and the ability to enroll subjects in accordance with
planned schedules; the effects of the COVID-19 pandemic and
measures to address the pandemic on the Company’s clinical trials,
supply chain and other third-party providers and development and
discovery operations; the Company’s dependence on its relationships
with its collaboration partners; the efficacy or safety of the
Company’s products and the products of the Company’s collaboration
partners; the acceptance of the Company’s products and the products
of the Company’s collaboration partners in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; greater than expected expenses; expenses relating to
litigation or strategic activities; and other risks detailed from
time to time in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report on Form 10-K for
the year ended December 31, 2021. The Company disclaims any intent
or obligation to update these forward-looking statements.
References: 1 Jaglowski SM,
et al. Graft-versus-Host Disease: Why Haven’t We Made More
Progress? Curr Opin Hematol. 2014;21(2):141-147 2 Zeiser R, et al.
Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host
Disease (REACH3). New England Journal of Medicine; July 2021. 3
Zeiser, R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute
Graft-versus-Host Disease (REACH2). New England Journal of
Medicine. April 2020. 4 Leukemia and Lymphoma Society.
Graft-Versus-Host Disease Overview. 2021. Available at:
https://www.lls.org/treatment/types-treatment/stem-cell-transplantation/graft-versus-host-disease
5 Jakavi (ruxolitinib) Summary of Product Characteristics. Novartis
Pharma AG; 2022. 6 Ferrara JL., et al. Graft-versus-host disease.
Lancet. 2009;373(9674):1550-1561. 7 Zeiser R., et al.
Pathophysiology of Chronic Graft-versus-Host Disease and
Therapeutic Targets. N Engl J Med. 2017 Dec 28;377(26):2565-2579 8
Jagasia MH, et al. National Institutes of Health Consensus
Development Project on Criteria for Clinical Trials in Chronic
Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging
Working Group report. Biol Blood Marrow Transplant. 2015. 9 Martin
PJ, Rizzo JD, Wingard JR, et al. First- and second-line systemic
treatment of acute graft-versus-host disease: recommendations of
the American Society of Blood and Marrow Transplantation. Biol
Blood Marrow Transplant. 2012;18(8):1150-1163. 10 Jakafi
(ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug
Administration.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504006208/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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