INDIANAPOLIS, May 4, 2021 /PRNewswire/ -- Eli Lilly and Company
(NYSE: LLY) announces new initiatives to help COVID-19 patients in
India as part of its commitment to
bring the full force of its scientific and medical expertise to
attack the coronavirus pandemic around the world. Lilly is offering
donations of baricitinib to the Indian government through Direct
Relief while simultaneously working with local Indian
pharmaceutical companies to execute royalty-free voluntary
licensing agreements to accelerate the manufacturing and
distribution of the medicine in India during the pandemic. An initial donation
of 400,000 baricitinib tablets is being made immediately available
to the Indian government for eligible hospitalized COVID-19
patients in India and Lilly will
work urgently to increase the quantity of donated product multifold
over the coming weeks.
On Monday, Lilly received emergency use authorization by the
Central Drugs Standard Control Organization, a division of Ministry
of Health, for its usage in eligible hospitalized COVID-19 patients
requiring supplemental oxygen, invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO). Baricitinib is an oral
medication currently registered in India for the treatment of moderate to severe
active rheumatoid arthritis in adult patients who have responded
inadequately to, or who are intolerant to one or more
disease-modifying anti-rheumatic drugs.
"With the COVID-19 crisis devastating India, hospitals are overwhelmed by the number
of cases and patients need access to potentially life-saving
treatments such as baricitinib," said David
A. Ricks, Lilly chairman and CEO. "We hope that our
donations as well as collaborations with other organizations speed
access to baricitinib and provide treatment options for these
patients."
As the global pandemic evolves, Lilly continues to evaluate
opportunities to provide treatments to COVID-19 patients in
countries around the world.
Authorized Use Under the EUA and Important Safety Information
for baricitinib (in the United
States) for COVID-19
Baricitinib is authorized for use under an Emergency Use
Authorization (EUA) in combination with remdesivir, for treatment
of suspected or laboratory confirmed coronavirus disease 2019
(COVID-19) in hospitalized adults and pediatric patients 2 years of
age or older, requiring supplemental oxygen, invasive mechanical
ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib has not been approved for the treatment of COVID-19,
but has been authorized for emergency use by the FDA. Baricitinib
is authorized under an EUA only for the duration of the declaration
that circumstances exist justifying the authorization of the EUA of
baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
For information on the authorized use of baricitinib and mandatory
requirements under the EUA, please review the FDA Letter of
Authorization, Fact Sheet for Healthcare Providers and Fact Sheet
for Patients, Parents and Caregivers (English; Spanish).
Important Safety Information about baricitinib for
COVID-19
The following provides essential safety information on the
unapproved use of baricitinib under the Emergency Use
Authorization.
Warnings
Serious Infections: Serious infections have occurred in
patients receiving baricitinib. Avoid the use of baricitinib with
known active tuberculosis. Consider if the potential benefits
outweigh the potential risks of baricitinib treatment in patients
with active serious infections other than COVID-19 or
chronic/recurrent infections.
Thrombosis: In hospitalized patients with COVID-19,
prophylaxis for venous thromboembolism is recommended unless
contraindicated. If clinical features of deep vein thrombosis or
pulmonary embolism occur, patients should be evaluated promptly and
treated appropriately.
Abnormal Laboratory Values: Evaluate at baseline and
thereafter according to local patient management practice. Monitor
closely when treating patients with abnormal baseline and
post-baseline laboratory values. Follow dose adjustments as
recommended in the Fact Sheet for Healthcare Providers for patients
with abnormal renal, hematological and hepatic laboratory values.
Manage patients according to routine clinical guidelines.
Hypersensitivity: If a serious hypersensitivity
occurs, discontinue baricitinib while evaluating the potential
causes of the reaction.
See Warnings and Precautions in the FDA-approved
full Prescribing Information for additional information on risks
associated with longer-term treatment with baricitinib.
Serious Side Effects: Serious venous thrombosis, including
pulmonary embolism, and serious infections have been observed in
COVID-19 patients treated with baricitinib and are known adverse
drug reactions of baricitinib.
There are limited clinical data available for baricitinib use in
coronavirus 2019 (COVID-19). Additional information regarding
baricitinib for its FDA-approved indication, including safety
information, may be found in the full Prescribing Information,
including Boxed Warning about Serious Infections, Malignancies, and
Thrombosis, and Medication Guide.
Use in Specific Populations
Pregnancy: Baricitinib should be used during pregnancy only
if the potential benefit justifies the potential risk for the
mother and the fetus.
Renal Impairment: There are limited data for baricitinib in
patients with severe renal impairment. Baricitinib is not
recommended for patients who are on dialysis, have end-stage renal
disease, or have acute kidney injury.
Hepatic Impairment: Baricitinib has not been studied in
patients with severe hepatic impairment. Baricitinib should only be
used in patients with severe hepatic impairment if the potential
benefit outweighs the potential risk.
BC HCP EUA ISI 19NOV2020
Click here for resources related
to Lilly's COVID-19 efforts and here for baricitinib's EUA.
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: Use of OLUMIANT in combination
with other JAK inhibitors, biologic disease-modifying antirheumatic
drugs (DMARDs), or with potent immunosuppressants such as
azathioprine and cyclosporine is not recommended.
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 ® (baricitinib)
OLUMIANT, a
once-daily, oral JAK inhibitor was discovered by Incyte and
licensed to Lilly. It is approved in the U.S. and more than 75
countries as a treatment for adults with moderate to severe
rheumatoid arthritis and was recently approved in the European
Union and Japan for the treatment
of adult patients with moderate to severe atopic dermatitis who are
candidates for systemic therapy. Olumiant was recently approved in
Japan for the treatment of
pneumonia associated with COVID-19 in hospitalized adult patients.
The U.S. FDA-approved labeling for Olumiant includes a Boxed
Warning for Serious Infections, Malignancy, and Thrombosis. See the
full Prescribing Information here. Baricitinib is also being
investigated in alopecia areata (AA), juvenile idiopathic arthritis
(JIA) and systematic lupus erythematosus (SLE).
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 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
being studied to understand their potential in treating
complications of COVID-19, and the company is collaborating with
partner companies to discover and develop novel antibody treatments
for COVID-19. Click here for resources related to Lilly's
COVID-19 efforts.
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 www.lilly.com and www.lilly.com/news. P-LLY
About Direct Relief
Direct Relief is a humanitarian aid organization, active in all 50
states and more than 80 countries, with a mission to improve the
health and lives of people affected by poverty or emergencies –
without regard to politics, religion, or ability to pay.
Lilly Cautionary Statement Regarding Forward-Looking
Statements
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 reflects Lilly's
current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of research, development and
commercialization. Among other things, there can be no guarantee
that planned or ongoing studies will be completed as planned, that
future study results will be consistent with the results to date,
that OLUMIANT will receive additional regulatory approvals or
authorizations or be commercially successful, that OLUMIANT will be
safe and effective as a treatment or successful preventative
therapy for COVID-19 or that Lilly's licensing arrangements
will provide an adequate supply of OLUMIANT. For further discussion
of these and other risks and uncertainties, see Lilly's most recent
Form 10-K and Form 10-Q filings with the United States Securities
and Exchange Commission. Except as required by law, Lilly
undertakes no duty to update forward-looking statements to reflect
events after the date of this release.
#
# #
Refer to:
|
Kristen Basu;
basu_kristen_porter@lilly.com; 317-447-2199 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investors)
|
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