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).
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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 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170414005051/en/
Lilly media:Danielle Neveles,
317-796-4564danielle.neveles@lilly.comorLilly investors:Phil
Johnson, 317-655-6874johnson_philip_l@lilly.comorIncyte
media:Catalina Loveman, 302-498-6171cloveman@incyte.comorIncyte
investors:Michael Booth, DPhil, 302-498-5914mbooth@incyte.com
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