WILMINGTON, Del.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24INCY&src=ctag” target=”_blank”gt;$INCYlt;/agt;–Incyte (Nasdaq:INCY) announced today that the U.S. Food and Drug
Administration (FDA) has extended the review period for the supplemental
New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the
treatment of patients with acute graft-versus-host disease (GVHD) who
have had an inadequate response to corticosteroids. The new Prescription
Drug User Fee Act (PDUFA) target action date is May 24, 2019.
The FDA extended the action date to allow time to review additional data
submitted by Incyte in response to the FDA’s information requests. The
submission of the additional information has been determined by the FDA
to constitute a Major Amendment to the sNDA, resulting in an extension
of the PDUFA goal date by three months.
“We remain confident in the data supporting our sNDA submission and look
forward to continued dialogue with the FDA throughout the review
process,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We
are committed to bringing ruxolitinib forward as a treatment option for
patients with acute GVHD.”
The sNDA for ruxolitinib for the treatment of patients with acute GVHD
was submitted in August 2018, and the FDA granted both Priority Review
and Breakthrough Therapy Designation. The FDA grants Priority Review to
medicines that have the potential to provide significant improvements in
the treatment of a serious disease. The FDA’s Breakthrough Therapy
Designation is designed to expedite the development and review of drugs
for serious conditions that have shown encouraging early clinical
results and may demonstrate substantial improvements over available
medicines. Additionally, the FDA granted ruxolitinib Orphan Drug
Designation for the treatment of GVHD, a designation granted to
investigational compounds intended for the safe and effective treatment,
diagnosis or prevention of rare diseases or disorders that affect fewer
than 200,000 people.
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 recipients
organs, leading to significant morbidity and mortality. There are two
forms of GVHD, acute and chronic, which can affect multiple organ
systems including the skin, gastrointestinal (digestive) tract and liver.
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food
and Drug Administration for treatment of people with polycythemia vera
(PV) who have had an inadequate response to or are intolerant of
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.
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.
Ruxolitinib is also being evaluated in patients with acute and chronic
GVHD who have an inadequate response to corticosteroids in the REACH2
and REACH3 clinical studies, respectively. It is expected that these two
pivotal studies will complete in 2019, and could support additional
regulatory submissions, in the U.S. by Incyte and ex-U.S. by Novartis,
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
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: low platelet
count, low red blood cell counts, 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 hepatitis B, 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.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at www.jakafi.com.
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.
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 whether or
when ruxolitinib might be approved in the U.S. for patients with acute
GVHD who have had an inadequate response to corticosteroids. 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 for the treatment of
patients with acute GVHD who have had an inadequate response to
corticosteroids, the results of additional data and additional analyses
of data from the REACH1 study, actions taken by regulatory authorities,
and other 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 September 30, 2018. Incyte disclaims any intent or
obligation to update these forward-looking statements.
Michael Booth, DPhil