INDIANAPOLIS, April 14, 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 issued a
complete response letter for the New Drug Application (NDA) of the
investigational medicine baricitinib, a once-daily oral medication
for the treatment of moderate-to-severe rheumatoid arthritis
(RA).
The letter indicates that the FDA is unable to approve the
application in its current form. Specifically, the FDA indicated
that additional clinical data are needed to determine the most
appropriate doses. The FDA also stated that additional data are
necessary to further characterize safety concerns across treatment
arms. The companies disagree with the agency's conclusions. The
timing of a resubmission will be based on further discussions with
the FDA.
"We are disappointed with this action. We remain confident in
the benefit/risk of baricitinib as a new treatment option for
adults with moderate-to-severe RA," said Christi Shaw, president of Lilly Bio-Medicines.
"We will continue to work with the FDA to determine a path forward
and ultimately bring baricitinib to patients in the U.S."
Lilly and Incyte submitted the NDA for baricitinib to the FDA in
January 2016, and in January 2017 announced the FDA's three-month
extension to allow time for review of additional data analyses.
Lilly is reaffirming both its financial guidance for 2017 and
its mid-term guidance for the remainder of this decade. Incyte is
evaluating the impact of the complete response on its
previously-issued milestone and R&D expense guidance for 2017;
any update will be provided on its Q1 2017 earnings call.
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., European Union and Japan in 2016, and was approved in the EU in
February 2017. It is 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 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 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 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 achieve its primary
endpoints, receive regulatory approvals, 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 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:
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