Jakafi is the first and only FDA-approved
treatment for patients with steroid-refractory acute
graft-versus-host disease (GVHD)
Incyte Corporation (Nasdaq:INCY) today announced that the U.S.
Food and Drug Administration (FDA) has approved Jakafi®
(ruxolitinib) for the treatment of steroid-refractory acute GVHD in
adult and pediatric patients 12 years and older. Jakafi is the
first and only FDA-approved treatment for this indication.
“For the first time, patients with steroid-refractory acute
GVHD, and the physicians that treat them, have an FDA-approved
treatment for this serious disease,” stated Hervé Hoppenot, Chief
Executive Officer, Incyte. “This approval is also an important
milestone for Incyte, as it marks the third indication for Jakafi
in the United States, further underscoring Incyte’s commitment to
delivering innovative medicines for patients in need. We are proud
of the impact Jakafi has had on patients’ lives to-date and are
dedicated to advancing our ongoing research in JAK inhibition to
serve more GVHD patients in the future.”
The approval was based on data from REACH1, an open-label,
single-arm, multicenter study of Jakafi in combination with
corticosteroids in patients with steroid-refractory grade II-IV
acute GVHD. Of the 71 patients recruited into REACH1, 49 patients
were refractory to steroids alone, 12 patients had received two or
more prior anti-GVHD therapies and 10 patients did not otherwise
meet the FDA definition of steroid-refractory. Jakafi was
administered at 5 mg twice daily, and the dose could be increased
to 10 mg twice daily after three days in the absence of
toxicity.
The efficacy of Jakafi was evaluated based upon Day 28 overall
response rate (ORR), defined as a complete response (CR), very good
partial response or partial response based on the Center for
International Blood and Marrow Transplant Research (CIBMTR)
criteria. The Day 28 ORR in the 49 patients refractory to steroids
alone was 57 percent with a CR rate of 31 percent. The most
frequently reported adverse reactions among all 71 study
participants were infections (55 percent) and edema (51 percent),
and the most common laboratory abnormalities were anemia (75
percent), thrombocytopenia (75 percent) and neutropenia (58
percent).
GVHD is a condition that can occur after an allogeneic stem cell
transplant (the transfer of stem cells from a donor) where the
donated cells initiate an immune response and attack the transplant
recipient’s organs, leading to significant morbidity and mortality.
There are two major forms of GVHD, acute and chronic, that can
affect multiple organ systems including the skin, gastrointestinal
(digestive) tract and liver. Patients who develop
steroid-refractory acute GVHD can progress to severe disease, with
one-year mortality rates of approximately 70 percent.1
“Every year in the United States, about half of the people who
develop acute GVHD do not respond adequately to steroids, making it
an extremely challenging disease to treat,” said Madan Jagasia,
M.B.B.S., M.S., M.M.H.C., a lead investigator on the REACH1 trial
and Professor of Medicine, Vanderbilt University Medical Center,
Department of Medicine, Division of Hematology-Oncology and Chief
Medical Officer, Vanderbilt-Ingram Cancer Center. “While allogeneic
stem cell transplants have the potential to transform people’s
lives, the onset of acute GVHD can significantly impact their
prognosis. I am excited that we now have Jakafi as a new treatment
option for acute GVHD patients that do not respond to
corticosteroids who, until now, have had limited choices.”
Previously, the FDA granted Jakafi Breakthrough Therapy
Designation and Orphan Drug Designation for the treatment of
patients with steroid-refractory acute GVHD, and the supplemental
New Drug Application (sNDA) was reviewed under the FDA’s Priority
Review program.
Jakafi will be made available to appropriate patients with
steroid-refractory acute GVHD immediately. Incyte is committed to
supporting patients and removing barriers to access medicines.
Eligible patients in the U.S. who are prescribed Jakafi have access
to IncyteCARES (Connecting to Access, Reimbursement, Education and
Support), a comprehensive program offering patient support,
including financial assistance and ongoing education and resources
to eligible patients. More information about IncyteCARES is
available by visiting www.incytecares.com or calling 1-855-4-Jakafi
(855-452-5234).
About REACH
The REACH clinical trial program is evaluating Jakafi in
patients with steroid-refractory GVHD. The REACH program includes
the Incyte-sponsored REACH1 trial, a prospective, open-label,
single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678)
evaluating Jakafi in combination with corticosteroids in patients
with steroid-refractory grade II-IV acute GVHD. For more
information about the REACH1 trial, please visit
https://clinicaltrials.gov/show/NCT02953678.
The REACH clinical program also includes the collaborative
Novartis-sponsored randomized pivotal Phase 3 trials in patients
with steroid-refractory acute GVHD (REACH2) and steroid-refractory
chronic GVHD (REACH3). Results from both REACH2 and REACH3 are
currently expected before the end of 2019.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of steroid-refractory acute GVHD in adult
and pediatric patients 12 years and older.
Jakafi is also indicated for treatment of polycythemia vera (PV)
in adults who have had an inadequate response to or are intolerant
of hydroxyurea as well as intermediate or high-risk myelofibrosis
(MF), including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF in adults.
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 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: for
certain types of MF and PV - low platelet count, low red blood cell
count, bruising, dizziness, and headache; and for acute GVHD – low
red blood cell counts, low platelet counts, low white blood cell
counts, infections and fluid retention.
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, have a high
level of fat in your blood (high blood cholesterol or
triglycerides), 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.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breast-feed during treatment with Jakafi
and for 2 weeks after the final dose.
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 web site 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 release contain predictions, estimates
and other forward-looking statements, including statements
regarding efforts to advance the Company’s ongoing research in JAK
inhibition and to help more GVHD patients in the future, the
potential efficacy, safety and therapeutic value of Jakafi®
(ruxolitinib) in patients with steroid-refractory GVHD and expected
timing of initial results of the REACH2 and REACH3 trials. 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 those risks detailed
from time to time in Incyte’s reports filed with the Securities and
Exchange Commission, including its Form 10-Q for the quarter ending
March 31, 2019. Incyte disclaims any intent or obligation to update
these forward-looking statements.
1 Shapira MY, Klimov A, Vipul S, et al. Regional intra-arterial
steroid treatment in 120 patients with steroid-resistant or
-dependent GvHD. Bone Marrow Transplant. 2017;52(10):1416-1422.
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version on businesswire.com: https://www.businesswire.com/news/home/20190524005348/en/
MediaJenifer Antonacci+1
302-498-7036jantonacci@incyte.com
Catalina Loveman+1 302-498-6171cloveman@incyte.com
InvestorsMichael Booth, DPhil+1
302-498-5914mbooth@incyte.com
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