INDIANAPOLIS, Jan. 13, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that the U.S. Food and Drug Administration (FDA) has extended
the review period for the new drug application (NDA) for
investigational baricitinib, a once-daily oral medication for the
treatment of moderate to severe rheumatoid arthritis (RA). The NDA
for baricitinib was submitted to the FDA in January 2016.
The FDA extended the action date to allow time to review
additional data analyses recently submitted by Lilly 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 NDA, resulting in an extension of the Prescription
Drug User Fee Act (PDUFA) goal date by three months.
"At Lilly, we are committed to improving the lives of people
with life-long chronic diseases such as rheumatoid arthritis, a
serious and disabling type of arthritis," said J. Anthony Ware, M.D., senior vice president,
product development and interim president of Lilly Bio-Medicines.
"We will continue to work closely with the FDA throughout the
review process and we believe that baricitinib has the potential to
be an effective treatment choice, especially for those patients for
whom current therapies are not adequately addressing their
disease."
This delay does not affect Lilly's previously-issued financial
guidance for 2017.
About Baricitinib
Baricitinib is a once-daily oral JAK
inhibitor currently in clinical studies for inflammatory and
autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2,
JAK3 and TYK2. JAK-dependent cytokines have been implicated in the
pathogenesis of a number of inflammatory and autoimmune diseases,
suggesting that JAK inhibitors may be useful for the treatment of a
broad range of inflammatory conditions.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases. Baricitinib was submitted for regulatory
review seeking marketing approval for the treatment of rheumatoid
arthritis in the U.S., European Union and Japan in Q1 2016. The European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) issued a positive opinion in December
2016, recommending the approval of baricitinib - which if
approved would be marketed as Olumiant®. Baricitinib is
also being studied in phase 2 trials for atopic dermatitis and
systemic lupus erythematosus, and a phase 3 trial for patients with
psoriatic arthritis is expected to be initiated in 2017.
About Rheumatoid Arthritis
Rheumatoid arthritis
is a systemic autoimmune disease characterized by inflammation and
progressive destruction of joints.[i,ii] More than
23 million people worldwide suffer from RA.[iii]
Approximately three times as many women as men have the disease.
Current treatment of RA includes the use of non-steroidal
anti-inflammatory drugs, oral conventional synthetic
disease-modifying antirheumatic drugs (csDMARDs), such as
methotrexate - the current standard of care - and injectable,
biological disease-modifying antirheumatic drugs (bDMARDs) that
target selected mediators implicated in the pathogenesis of
RA.[iv] Despite current treatment options, many patients
do not reach their therapeutic goals or sustained
remission.[v,vi] There remains an important need to
provide additional treatments to improve overall patient care.
About Baricitinib Phase 3 Trials
Lilly and
Incyte conducted four pivotal phase 3 clinical trials of
baricitinib in patients with moderate to severe active rheumatoid
arthritis to support regulatory submission in most countries. Two
of the four studies included pre-specified comparisons to approved
DMARDs: one to methotrexate (RA-BEGIN) and one to adalimumab
(RA-BEAM). An additional phase 3 study was initiated to support
clinical development in China. The
clinical trial program includes a wide range of patients including
those who are methotrexate-naïve, inadequate responders to
methotrexate, inadequate responders to conventional synthetic
disease modifying antirheumatic drugs, or inadequate responders to
biologic DMARDs including TNF inhibitors. Patients completing any
of the phase 3 studies can enroll in a long-term extension study.
For additional information on this clinical trial program, please
visit www.clinicaltrials.gov.
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.
About Eli Lilly and Company
Lilly is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us
at www.lilly.com and newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about baricitinib as a potential treatment for
patients with rheumatoid arthritis and reflects Lilly's and
Incyte's current beliefs. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of development and commercialization. Among other things,
there can be no guarantee that baricitinib will achieve its primary
study endpoints or receive additional regulatory approvals.
For further discussion of these and other risks and uncertainties,
see Lilly's and Incyte's most recent respective Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly and Incyte undertake
no duty to update forward-looking statements to reflect events
after the date of this release.
i American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp.
Accessed December 5, 2016.
ii Hand Clinics, Advances in the Medical
Treatment of Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed December 5, 2016.
iii WHO Global Burden of Disease Report,
(table 7, page 32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
Acce Accessed December 5, 2016.
iv Arthritis Foundation, Medications for Rheumatoid
Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php.
Accessed December 5, 2016.
v Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed December 5, 2016.
vi Sustained rheumatoid arthritis remission is uncommon
in clinical practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
December 5, 2016.
Refer
to:
|
Scott MacGregor;
jsmacgregor@lilly.com; +1-317-440-4699 (Lilly media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly
investors)
|
|
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
|
|
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
|
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SOURCE Eli Lilly and Company