Baricitinib, marketed as Olumiant, is the first JAK
inhibitor approved to treat RA in the EU
INDIANAPOLIS, Feb. 13, 2017 /CNW/ -- Eli Lilly and Company
(NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today
that the European Commission has granted marketing authorisation
for Olumiant® (baricitinib) 4 mg and 2 mg film-coated
tablets in Europe for the
treatment of moderate-to-severe active rheumatoid arthritis (RA) in
adult patients who have responded inadequately to, or who are
intolerant to, one or more disease-modifying antirheumatic drugs
(DMARDs).
This is the first regulatory approval around the world for
Olumiant -- the first JAK inhibitor approved to treat RA in the
European Union -- which may be used as monotherapy or in
combination with methotrexate. In clinical studies, Olumiant has
demonstrated significant improvement in the signs and symptoms of
RA compared to standard of care therapies such as methotrexate and
Humira®* (adalimumab) with background methotrexate.
"Despite clinical advances in treatment, many people with RA
continue to struggle with the debilitating effects of this disease,
which can lead to long-term joint damage and disability," said
J. Anthony Ware, M.D., senior vice
president for product development and interim president, Lilly
Bio-Medicines. "We believe that as a next-generation therapy in the
EU, Olumiant will advance RA treatment by helping patients with
moderate-to-severe disease feel better quickly."
Baricitinib's phase 3 program includes four completed clinical
studies in a wide range of adult patients with RA, from
treatment-naïve patients to those who are inadequate responders to
TNF inhibitors. Two of those studies, RA-BEGIN and RA-BEAM,
included a pre-specified comparison against either methotrexate or
Humira with background methotrexate. Patients completing any of the
phase 3 studies could enroll in a long-term extension study.
"The European Commission's approval of baricitinib is an
exciting milestone for the RA community in the EU," said
Steven Stein, M.D., chief medical
officer, Incyte Corporation. "We're confident that baricitinib will
help to meet the needs of healthcare providers and their patients
as they work toward achieving long-term treatment goals."
As a result of the approval of Olumiant by the European
Commission, Incyte becomes eligible to receive a milestone payment
of $65 million from Lilly, which it expects to record in full
in the first quarter of 2017.
About Baricitinib
Baricitinib is a once-daily
oral, selective and reversible JAK1 and JAK2 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. 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 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.
*The brand listed is a trademark of AbbVie and is not a
trademark of Eli Lilly and Company or Incyte Corporation. The maker
of this brand is not affiliated with and does not endorse Lilly,
Incyte or their products.
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 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 future study results will be consistent with the
results to date or that baricitinib will achieve its primary study
endpoints, receive additional 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 January 9, 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 January 9, 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 January 9, 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 January 9, 2017.
v Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed January 9, 2017.
vi Sustained rheumatoid arthritis remission is uncommon
in clinical practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
January 9, 2017.
Refer
to:
|
Scott MacGregor;
jsmacgregor@lilly.com; +1-317-440-4699 (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; Incyte Corporation