INDIANAPOLIS, July 25, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that a resubmission to the U.S. Food and Drug Administration
(FDA) for the New Drug Application (NDA) for baricitinib, a
once-daily oral medication for the treatment of moderate-to-severe
rheumatoid arthritis (RA), will be delayed beyond 2017. The
companies will be further discussing the path forward with the
agency and evaluating options for resubmission, including the
potential for an additional clinical study, as requested by the
FDA. The length of time to a resubmission for the NDA will depend
on which option the companies pursue and further FDA discussions,
but is anticipated to be a minimum of 18 months.
"We disagree with the FDA's conclusions, and believe the
existing comprehensive clinical data demonstrate there is a
positive benefit/risk profile that supports baricitinib's approval
as a new treatment option for people suffering from RA in
the United States," said
Christi Shaw, president of Lilly
Bio-Medicines. "We are disappointed that resubmission will not
occur this year, but are committed to bringing baricitinib to
people with RA and we will work with the FDA on the path
forward."
The FDA has indicated that a new clinical study is necessary for
a resubmission in order to further characterize the benefit/risk
across doses, in light of the observed imbalance in thromboembolic
events that occurred during the placebo-controlled period of the RA
clinical program. This request for an additional clinical study
does not impact the ongoing clinical trials for baricitinib.
The NDA for RA contained the results of four positive Phase 3
clinical trials that met their primary endpoints and in which 3,100
patients were enrolled, across the full spectrum of RA patients
from treatment-naïve to highly-treatment refractory. Thromboembolic
events – diagnosed as deep venous thrombosis (DVT) and pulmonary
embolism (PE) – were reported in five patients receiving
baricitinib during the controlled period of two of seven completed
Phase 2 or Phase 3 trials in RA. Although an imbalance was observed
during the placebo controlled period of the RA clinical trials, the
rate of these events in the overall baricitinib clinical program
was consistent with that seen among the general population of
treated RA patients.
In the European Union, where baricitinib 2-mg and 4-mg tablets
have been approved since February
2017, the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) recently agreed to update
the label with a precaution for patients who have risk factors for
DVT and PE. In Japan, where
baricitinib was also recently approved, the label includes a
similar precaution.
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. Baricitinib was approved in the
EU in February 2017. In April 2017, the U.S. Food and Drug Administration
issued a Complete Response Letter on the New Drug Application for
baricitinib. Baricitinib was also approved in Kuwait and Switzerland in June
2017 and approved in Japan
in July 2017 for the treatment of RA.
Baricitinib remains under review in other markets. It is also being
studied in Phase 2 trials for atopic dermatitis and systemic lupus
erythematosus. The Phase 3 trial for psoriatic arthritis has been
delayed and will not begin in 2017 as previously
expected.
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 bDMARDs 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 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