INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today
initial data emerging from the Adaptive COVID-19 Treatment Trial
(ACTT-2) sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH). ACTT-2 included more than 1,000 patients and began on
May 8 to assess the efficacy and
safety of a 4-mg dose of baricitinib plus remdesivir versus
remdesivir in hospitalized patients with COVID-19. Baricitinib in
combination with remdesivir met the primary endpoint of reduction
of time to recovery in comparison with remdesivir.
Study investigators noted an approximately one-day reduction in
median recovery time for the overall patient population treated
with baricitinib in combination with remdesivir versus those
treated with remdesivir. This finding was statistically
significant. Recovery was defined as the participant being well
enough for hospital discharge, meaning the participant either no
longer required supplemental oxygen or ongoing medical care in the
hospital, or was no longer hospitalized at Day 29. The study also
met a key secondary endpoint comparing patient outcomes at Day 15
using an ordinal 8-point scale ranging from fully recovered to
death.
An independent data and safety monitoring board overseeing the
double-blind, randomized controlled trial met regularly throughout
the trial to review safety data. Additional analyses are ongoing to
understand other clinical outcome data, including mortality and
safety data. NIAID is expected to publish full details of the study
in a peer-reviewed journal.
"We are pleased with these data from the ACTT-2 study," said
Patrik Jonsson, Lilly senior vice
president and president of Lilly Bio-Medicines. "There is an urgent
need to identify COVID-19 treatments, and we will continue to work
with NIAID to understand these data and next steps on baricitinib's
role moving forward. We appreciate NIAID selecting baricitinib for
inclusion in this important study and the participants,
investigators and collaborators for the vital roles they
played."
"These findings from ACTT-2 are another step as we improve the
care of these patients," said Andre
Kalil, M.D., professor at the University of Nebraska Medical Center and a
principal investigator of the ACTT studies. "These data may help us
to better understand baricitinib's potential role in the treatment
of COVID-19."
Based on the ACTT-2 data, Lilly plans to discuss the potential
for emergency use authorization (EUA) with the U.S. Food and Drug
Administration (FDA) and to explore similar measures with other
regulatory agencies for baricitinib as a treatment of hospitalized
patients with COVID-19. If authorized for use, Lilly will propose
that baricitinib be available through commercial channels and will
work with hospitals and governments to ensure patient access. Lilly
will continue to create adequate supply for rheumatoid arthritis
(RA) patients and ensure baricitinib remains available in countries
where it is approved. In the U.S., baricitinib is approved for RA
patients at a 2-mg daily dose; an EUA would potentially authorize a
4-mg dose for COVID-19.
Lilly will review the ACTT-2 data with NIAID and assess any
impact on COV-BARRIER, the Phase 3 randomized, double-blind,
placebo-controlled study it initiated in June to evaluate the
efficacy and safety of baricitinib versus background therapy in
hospitalized adults with COVID-19 in the U.S., Europe, Asia
and Latin America.
"As a company, we've moved quickly to develop and evaluate
medicines for patients for the prevention and treatment of
COVID-19," said Daniel Skovronsky,
M.D., Ph.D., Lilly senior vice president and chief scientific
officer. "These data allow us to better understand baricitinib's
role in potentially improving outcomes for hospitalized COVID-19
patients, and we look forward to continuing this research alongside
our other initiatives to combat COVID-19."
Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte
and marketed as OLUMIANT®, is approved in more than 70
countries as a treatment for adults with moderately to severely
active RA. Studying baricitinib in controlled trials is important
in order to better characterize its potential benefits and
understand the safety of its use as a COVID-19 treatment. The U.S.
prescribing information for the approved use of baricitinib for RA
includes boxed warnings regarding the use of baricitinib, including
warnings about risk for developing blood clots and serious
infections.
Lilly is also currently supporting ongoing multisite and
single-site investigator-initiated trials in Europe and North
America for hospitalized patients with COVID-19
infections.
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical
expertise to attack the coronavirus pandemic around the world.
Existing Lilly medicines are now being studied to understand their
potential in treating complications of COVID-19, and the company is
collaborating with two partner companies to discover novel antibody
treatments for COVID-19. Lilly intends to test both single antibody
therapy as well as combinations of antibodies (sometimes known as
antibody cocktails) as potential therapeutics for COVID-19. Click
here for media resources related to Lilly's COVID-19 efforts.
Indication and Usage for OLUMIANT (baricitinib) tablets
(in the United States) for RA
patients
OLUMIANT® (baricitinib) 2-mg is indicated for
the treatment of adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response to one or
more tumor necrosis factor (TNF) antagonist
therapies. Limitation of Use: Not recommended for use in
combination with other JAK inhibitors, biologic disease-modifying
antirheumatic drugs (DMARDs), or with potent immunosuppressants
such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib)
TABLETS
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND
THROMBOSIS
SERIOUS INFECTIONS: Patients treated with
Olumiant are at risk for developing serious infections that may
lead to hospitalization or death. Most patients who developed these
infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids. If a serious infection develops,
interrupt Olumiant until the infection is controlled. Reported
infections include:
- Active tuberculosis (TB), which may present with pulmonary
or extrapulmonary disease. Test patients for latent TB before
initiating Olumiant and during therapy. If positive, start
treatment for latent infection prior to Olumiant use.
- Invasive fungal infections, including candidiasis and
pneumocystosis. Patients with invasive fungal infections may
present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic
pathogens.
Carefully consider the risks and benefits of Olumiant prior
to initiating therapy in patients with chronic or recurrent
infection.
Closely monitor patients for the development of signs and
symptoms of infection during and after treatment with Olumiant
including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating
therapy.
MALIGNANCIES: Lymphoma and other
malignancies have been observed in patients treated with
Olumiant.
THROMBOSIS: Thrombosis, including deep
venous thrombosis (DVT) and pulmonary embolism (PE), has been
observed at an increased incidence in patients treated with
Olumiant compared to placebo. In addition, there were cases of
arterial thrombosis. Many of these adverse events were serious and
some resulted in death. Patients with symptoms of thrombosis should
be promptly evaluated.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS: The most common serious
infections reported with Olumiant included pneumonia, herpes
zoster and urinary tract infection. Among opportunistic infections,
tuberculosis, multidermatomal herpes zoster, esophageal
candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis,
cytomegalovirus and BK virus were reported with Olumiant. Some
patients have presented with disseminated rather than local disease
and were often taking concomitant immunosuppressants such as
methotrexate or corticosteroids. Avoid Olumiant in patients with an
active, serious infection, including localized infections. Consider
the risks and benefits of treatment prior to initiating Olumiant in
patients:
- with chronic or recurrent infection
- who have been exposed to TB
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis
or endemic mycoses; or
- with underlying conditions that may predispose them to
infection.
Closely monitor patients for infections during and after
Olumiant treatment. Interrupt Olumiant if a patient develops a
serious infection, an opportunistic infection, or sepsis. Do not
resume Olumiant until the infection is controlled.
Tuberculosis – Before initiating
Olumiant evaluate and test patients for latent or active
infection and treat patients with latent TB with standard
antimycobacterial therapy. Olumiant should not be given to patients
with active TB. Consider anti-TB therapy prior to initiating
Olumiant in patients with a history of latent or active TB in whom
an adequate course of treatment cannot be confirmed, and for
patients with a negative test for latent TB but who have risk
factors for TB infection. Monitor patients for TB during Olumiant
treatment.
Viral Reactivation – Viral reactivation,
including cases of herpes virus reactivation (e.g., herpes zoster),
were reported in clinical studies with Olumiant. If a patient
develops herpes zoster, interrupt Olumiant treatment until the
episode resolves.
The impact of Olumiant on chronic viral hepatitis reactivation
is unknown. Screen for viral hepatitis in accordance with clinical
guidelines before initiating Olumiant.
MALIGNANCY AND LYMPHOPROLIFERATIVE
DISORDERS: Malignancies were observed in Olumiant
clinical studies. Consider the risks and benefits of Olumiant prior
to initiating therapy in patients with a known malignancy other
than a successfully treated non-melanoma skin cancer (NMSC) or when
considering continuing Olumiant in patients who develop a
malignancy. NMSCs were reported in patients treated with Olumiant.
Periodic skin examination is recommended for patients who are at
increased risk for skin cancer.
THROMBOSIS: Thrombosis, including DVT and
PE, has been observed at an increased incidence in Olumiant-treated
patients compared to placebo. In addition, arterial thrombosis
events in the extremities have been reported in clinical studies
with Olumiant. Many of these adverse events were serious and some
resulted in death. There was no clear relationship between platelet
count elevations and thrombotic events. Use Olumiant with
caution in patients who may be at increased risk of thrombosis. If
clinical features of DVT/PE or arterial thrombosis occur, evaluate
patients promptly and treat appropriately.
GASTROINTESTINAL PERFORATIONS: Gastrointestinal
perforations have been reported in Olumiant clinical studies,
although the role of JAK inhibition in these events is not known.
Use Olumiant with caution in patients who may be at increased
risk for gastrointestinal perforation (e.g., patients with a
history of diverticulitis). Promptly evaluate patients who present
with new onset abdominal symptoms for early identification of
gastrointestinal perforation.
LABORATORY ABNORMALITIES:
Neutropenia – Olumiant treatment was
associated with an increased incidence of neutropenia (absolute
neutrophil count [ANC] <1000 cells/mm3) compared
to placebo. Avoid initiation or interrupt Olumiant treatment in
patients with an ANC <1000 cells/mm3. Evaluate
at baseline and thereafter according to routine patient
management.
Lymphopenia – Absolute lymphocyte
count (ALC) <500 cells/mm3 were reported in
Olumiant clinical trials. Lymphocyte counts less than the lower
limit of normal were associated with infection in patients treated
with Olumiant, but not placebo. Avoid initiation or interrupt
Olumiant treatment in patients with an ALC
<500 cells/mm3. Evaluate at baseline and
thereafter according to routine patient management.
Anemia – Decreases in hemoglobin
levels to <8 g/dL were reported in Olumiant clinical
trials. Avoid initiation or interrupt Olumiant treatment in
patients with hemoglobin <8 g/dL. Evaluate at baseline and
thereafter according to routine patient management.
Liver Enzyme Elevations – Olumiant
treatment was associated with increased incidence of liver enzyme
elevation compared to placebo. Increases of ALT ≥5x upper limit of
normal (ULN) and increases of AST ≥10x ULN were observed in
patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient
management. Promptly investigate the cause of liver enzyme
elevation to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver
injury is suspected, interrupt Olumiant until this diagnosis is
excluded.
Lipid Elevations – Treatment with
Olumiant was associated with increases in lipid parameters,
including total cholesterol, low-density lipoprotein cholesterol
and high-density lipoprotein cholesterol. Assess lipid parameters
approximately 12 weeks following Olumiant initiation. Manage
patients according to clinical guidelines for the management of
hyperlipidemia.
VACCINATIONS: Avoid use of live vaccines with
Olumiant. Update immunizations in agreement with current
immunization guidelines prior to initiating Olumiant therapy.
HYPERSENSITIVITY: Reactions such as angioedema,
urticaria, and rash that may reflect drug sensitivity have been
observed in patients receiving Olumiant, including serious
reactions. If a serious hypersensitivity reaction occurs, promptly
discontinue Olumiant while evaluating the potential causes of the
reaction.
ADVERSE REACTIONS
Most common adverse reactions
include: upper respiratory tract infections (16.3%, 11.7%), nausea
(2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%,
0.4%) for Olumiant 2 mg and placebo, respectively.
USE IN SPECIFIC POPULATIONS
PREGNANCY AND LACTATION: No information is available
to support the use of Olumiant in pregnancy or lactation. Advise
women not to breastfeed during treatment with Olumiant.
HEPATIC AND RENAL IMPAIRMENT: Olumiant is not
recommended in patients with severe hepatic impairment or in
patients with severe renal impairment.
Please click to access full Prescribing
Information, including Boxed Warning about Serious Infections,
Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About OLUMIANT®
OLUMIANT is a once-daily,
oral JAK inhibitor approved in the U.S. for the treatment of adults
with moderately to severely active rheumatoid arthritis who have
had an inadequate response to one or more TNF inhibitor therapies,
and approved outside of the U.S. for patients with moderately to
severely active rheumatoid arthritis who have had an inadequate
response to one or more DMARDs.i 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.ii OLUMIANT
has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to
JAK3; however, the relevance of inhibition of specific JAK enzymes
to therapeutic effectiveness is not currently
known.i
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.
About Eli Lilly and Company
Lilly is a
global health care leader that unites caring with discovery to
create medicines that 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
lilly.com and lilly.com/newsroom. P-LLY
About Incyte
Incyte is
a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about OLUMIANT (baricitinib) as a potential treatment for
patients with COVID-19 and as a treatment for patients with
rheumatoid arthritis, and about the supply of OLUMIANT, and
reflects Lilly's and Incyte's current beliefs. This press release
also contains a forward-looking statement about Lilly's potential
antibody treatments for COVID-19. 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 OLUMIANT will
receive additional regulatory approvals or continue to be
commercially successful, that we can provide an adequate supply of
OLUMIANT in all circumstances, or that potential antibody
treatments will be safe and effective. 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 Olumiant Prescribing Information, 2020.
ii Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
Refer to:
|
Kristen Porter Basu;
basu_kristen_porter@lilly.com; 317-447-2199 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (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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