INDIANAPOLIS, April 23, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that the U.S. Food and Drug Administration's (FDA) Arthritis
Advisory Committee recommended approval of the 2-mg dose of
baricitinib, a once-daily oral medication for the treatment of
moderately-to-severely active rheumatoid arthritis (RA) for adult
patients who have had an inadequate response or intolerance to
methotrexate. While the Advisory Committee unanimously supported
the efficacy of the 4-mg dose of baricitinib, it did not recommend
approval of the 4-mg dose of baricitinib for the proposed
indication based on the adequacy of the safety and benefit-risk
profiles.
"We are confident that baricitinib, if approved, can help people
in the U.S. manage the challenges of living with RA," said
Christi Shaw, president of Lilly
Bio-Medicines. "While we are disappointed with the Advisory
Committee's assessment of the data for the 4-mg dose, we are
confident in the positive benefit-risk profile of both the 2-mg and
the 4-mg doses. We look forward to continuing our work with the FDA
on our New Drug Application (NDA) and are hopeful that baricitinib
will receive approval in the coming months."
Baricitinib 2-mg and 4-mg doses are approved in more than 40
countries, including the member states of the European Union and
Japan.
For both doses, the Advisory Committee voted to support the
assessment that baricitinib's data provide substantial evidence of
efficacy. For the 2-mg dose, the Advisory Committee voted in favor
of the assessment that baricitinib's safety data adequately support
its approval. For the 4-mg dose, the Advisory Committee voted
against the assessment that baricitinib's safety data was adequate
to support its approval based on the proposed indication.
The Advisory Committee's recommendation was based on
baricitinib's global development program, which included four
completed Phase 3 studies. In total, 3,492 patients, who
represented a range of treatment experiences, received baricitinib
in the global RA development program. The Phase 3 studies evaluated
baricitinib's treatment impact related to RA signs and symptoms,
physical function, joint damage progression and other
patient-reported outcomes. The Phase 3 program also evaluated
recognized risks for RA patients, including serious infection,
malignancy, major adverse cardiovascular events (MACE), venous
thromboembolism (VTE), and gastrointestinal perforations, along
with key laboratory changes. The safety profile of baricitinib is
based on 7,860 patient-years of exposure.
"Despite advances in the management of RA over the last 20
years, which include early treatment, optimized use of traditional
therapies for rheumatic disease and the advent of newer medications
such as biologics, many patients are still struggling to meet
treatment targets, and live with debilitating pain, fatigue and
other symptoms of RA," said Peter Taylor, MA, PhD, professor,
University of Oxford, an expert who
attended the Advisory Committee Meeting. "Baricitinib could be a
promising option for RA patients in the U.S. who are not achieving
adequate disease control with currently available treatments."
The FDA is not required to follow the Advisory Committee's
recommendation, but will consider it during its review of the NDA
for baricitinib.
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. To date, baricitinib has been approved in more than 40
countries and remains under review in several other markets.
About Rheumatoid Arthritis
Rheumatoid arthritis is a
systemic autoimmune disease characterized by inflammation and
progressive destruction of joints.1,2 More than 23
million people worldwide suffer from
RA.3 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.4 Despite current treatment options, many patients do
not reach their therapeutic goals or sustained
remission.5,6 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 moderately-to-severely 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 concluded
and is under review to support registration 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 www.lilly.com/newsroom/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.
_________________________
1 American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp.
Accessed April 23, 2018.
2 Hand Clinics, Advances in the Medical Treatment of
Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed April 23, 2018.
3 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 April 23, 2018.
4 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 April 23, 2018.
5 Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed April 23, 2018.
6 Sustained Rheumatoid Arthritis Remission is Uncommon
in Clinical Practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
April 23, 2018.
Refer to:
Danielle Neveles;
danielle.neveles@lilly.com; 317-796-4564 (Lilly media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (Lilly investors)
Catalina Loveman;
cloveman@incyte.com; 302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; 302-498-5914 (Incyte investors)
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