INDIANAPOLIS, Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ: INCY) are sharing
additional data showing baricitinib in combination with remdesivir
reduced time to recovery and improved clinical outcomes for
patients with COVID-19 infection compared with remdesivir. This
finding was part of additional efficacy and safety data 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) presented today by John
Beigel, M.D., associate director for clinical research in the
Division of Microbiology and Infectious Diseases at NIAID. These
data were presented at a special International Society for
Influenza and other Respiratory Virus Diseases Antiviral Group
(isirv-AVG) Virtual Conference on 'Therapeutics for COVID-19.' The
largest benefits were observed in patients requiring supplemental
oxygen (grade 5 on the eight-point ordinal scale) and those who
required high-flow oxygen/non-invasive ventilation (grade 6) at
baseline.
New data presented today provide a better understanding of the
improved clinical outcomes in hospitalized adults with COVID-19
infection who received baricitinib, including data for mortality.
As previously reported, ACTT-2 achieved the primary endpoint,
demonstrating that the overall patient population treated with
baricitinib in combination with remdesivir improved their median
time to recovery from 8 to 7 days in comparison to remdesivir, a
12.5% improvement (incidence rate ratio: 1.16; 95% CI: 1.01, 1.32;
p=0.04). 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 pre-specified secondary endpoint. Using the ordinal scale
that ranged from recovered to death, the odds of improvement in
clinical status at Day 15 were 30% greater in patients being
treated with baricitinib in combination with remdesivir compared
with remdesivir (odds ratio 1.3; 95% CI: 1.0, 1.6; p=0.04).
A numerical decrease in death (35%) through Day 29 was observed
in patients treated with baricitinib plus remdesivir compared to
remdesivir in the overall population (5.1% vs. 7.8%, respectively;
hazard ratio: 0.65; 95% CI: 0.39, 1.08; p=0.09). The reduction in
mortality was more pronounced for patients receiving oxygen, as
mortality at Day 29 was 60% lower and 43% lower for the OS5 and OS6
subgroups respectively. No new safety signals were observed for
baricitinib-treated patients in this study. NIAID authors are
working to have the full analysis completed and a peer-reviewed
manuscript will be made available soon.
"We are excited that these results add to the potential role for
baricitinib to treat hospitalized COVID-19 patients," said
Ilya Yuffa, Lilly senior vice
president and president of Lilly Bio-Medicines. "Lilly is committed
to identifying impactful preventions and treatments, and we are
engaged in discussions with the FDA regarding the potential to make
baricitinib available to hospitalized patients as quickly as
possible."
Lilly is continuing conversations with the U.S. Food and Drug
Administration (FDA) around the potential for Emergency Use
Authorization (EUA) of baricitinib, a JAK1/JAK2 inhibitor licensed
to Lilly from Incyte, to treat hospitalized patients
with COVID-19. In the U.S., baricitinib has not been approved by
the FDA to treat COVID-19, and the efficacy and safety of
baricitinib for the treatment of COVID-19 has not been
established.
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 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 is testing both single antibody therapy as well as
combinations of antibodies as potential therapeutics for COVID-19.
Click here for media resources related to Lilly's COVID-19
efforts.
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.1 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.2 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.1
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 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, 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.
1 Olumiant Prescribing Information, 2020.
2 Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
Refer
to:
Kristen Basu;
basu_kristen_porter@lilly.com; +1-317-447-2199 (Lilly media)
Kevin Hern; hern_kevin_r@lilly.com;
+1-317-277-1838 (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