INDIANAPOLIS, Aug. 30, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that, after discussions with the U.S. Food and Drug
Administration (FDA) in late August, Lilly will resubmit the New
Drug Application (NDA) for baricitinib before the end of
January 2018. The resubmission
package will include new safety and efficacy data. The companies
anticipate the FDA will classify the application as a Class II
resubmission, which will start a new six-month review cycle.
Baricitinib is a once-daily oral investigational medication for the
treatment of patients with moderate-to-severe rheumatoid arthritis
(RA).
"We are committed to making life better for people living with
RA. There is a significant unmet need for Americans suffering from
this debilitating disease in spite of available therapies," said
Christi Shaw, president of Lilly
Bio-Medicines. "We are pleased with the opportunity to provide our
resubmission package for baricitinib sooner than anticipated and
look forward to continuing to work with the FDA as we seek to bring
baricitinib to people with RA in the U.S."
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, including
rheumatoid arthritis.
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., the European Union and Japan in 2016. Baricitinib was approved in the
EU in February 2017 and in
Japan in July 2017. In April
2017, the U.S. Food and Drug Administration issued a
Complete Response Letter on the New Drug Application for
baricitinib. Baricitinib remains under review in other markets. It
is also being studied for the treatment of atopic dermatitis and
systemic lupus erythematosus. The Phase 3 program for psoriatic
arthritis is expected to begin in 2018.
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
successful 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 recently concluded 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 bDMARDs including
TNF inhibitors. Patients completing any of the Phase 3 studies were
able to 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
receive regulatory approval or be commercially successful.
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 July 21, 2017.
ii Hand Clinics, Advances in the Medical
Treatment of Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed July 21, 2017.
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.
Accessed July 21, 2017.
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 July 21, 2017.
v Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed July 21, 2017.
vi Sustained rheumatoid arthritis remission is uncommon
in clinical practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
July 21, 2017.
Refer to:
|
Danielle Neveles;
danielle.neveles@lilly.com; +1-317-796-4564 (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