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.
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SOURCE Eli Lilly and Company