Updates: Lilly's Global COVID-19 Response

Eli Lilly and Company  | November 25, 2020

READ: Baricitinib receives Emergency Use Authorization by the U.S. Food and Drug Administration for the treatment of hospitalized patients with COVID-19.

Lilly continues to closely monitor the COVID-19 pandemic and its global impact. As this is an evolving topic, Lilly will include relevant announcements and information on this page.

  • If the COVID-19 pandemic has impacted your ability to afford or access your Lilly medicine, contact us via these options.

  • If you have questions about a Lilly medicine, call The Lilly Answers Center at 1-800-545-5979 (1-800-Lilly-Rx). See more information here.

  • If you have insulin access and affordability questions, call the Lilly Diabetes Solution Center at 1-833-808-1234. See more information here.

  • For Indiana Residents: Lilly is not currently offering COVID-19 drive-through testing to the public. Please visit info.covid19testing.lilly.com for more information on COVID-19 testing in Indiana.

  • Centers for Disease Control information can be found at cdc.gov/coronavirus.

On COVID-19 and Clinical Trials:

  • If you are a clinical investigator, or you represent a hospital or clinical site, and are interested in participating as an investigator or site in one of Lilly’s clinical trials for a potential COVID-19 treatment, call 1-877-CT-LILLY (1-877-285-4559) or email covid19potentialsite@lilly.com.

  • Patients interested in participating in one of our clinical trials for a potential COVID-19 treatment should visit Lilly TrialGuide for information regarding eligibility for ongoing trials.

Here’s what we’re doing at Lilly to make sure our employees and their families are safe, and to ensure people have access to Lilly medicines:

News Releases, Resources and Multimedia

November

October

September

August

July

June

May

April

March

All-Updates Timeline

November 25, 2020

The National Institute of Allergy and Infectious Diseases (NIAID) announced today its fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4). The trial will evaluate a Lilly medicine and has begun to enroll hospitalized adults with COVID-19 who require supplemental oxygen.

November 20, 2020

Today, Health Canada granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization.

Note: The use of bamlanivimab is permitted under an interim authorization delivered in accordance with section 5 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

November 19, 2020

The U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization today for an existing Lilly medicine to be made available for hospitalized patients with COVID-19 who require oxygen. It is the second EUA issued for a Lilly medicine. Learn more in this video story.

Note: The FDA grants Emergency Use Authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.

November 10, 2020

Lilly's chief scientific officer, Daniel Skovronsky, wrote an article speaking to the scientific efforts that led to our antibody therapy's Emergency Use Authorization: "Creating a medicine from scratch and guiding it successfully through the clinical trial process often takes 10 years. In the case of this antibody therapy, it took less than one."

Previously, Lilly CEO Dave Ricks shared more about this emergency authorization in a video article.

November 9, 2020

Today, the FDA granted Emergency Use Authorization (EUA) for Lilly's investigational neutralizing antibody. Bamlanivimab (LY-CoV555) has been authorized for the treatment of mild to moderate COVID-19 in certain populations. “This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said Dave Ricks, Lilly's chairman and CEO. “The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.”

Learn more about Lilly's COVID-19 approach.

Note: The FDA grants Emergency Use Authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.

October 28, 2020

Today we announced an agreement with the U.S. government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab to fight COVID-19, with potential for purchase of an additional 650,000 vials. Patients will have no out-of-pocket costs for the medication. Read our CEO Dave Ricks' thoughts on Lilly's access and affordability principles for our neutralizing antibodies, and view our related infographics about those principles and key clinical trials.

Additionally, The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Lilly's bamlanivimab (LY-CoV555) – a neutralizing antibody – in the COVID-19 outpatient setting.

October 26, 2020

The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab. Read Lilly's full statement about NIH's ACTIV-3 trial.

October 20, 2020

Recently, one of Lilly's manufacturing plants underwent a routine Food and Drug Administration (FDA) general surveillance inspection. The inspectors had some findings related to data handling, and thus we received an Official Action Indicated (OAI) notice. Given that this plant, located in Branchburg, NJ, is among several worldwide that produces bamlanivimab, one of our COVID-19 neutralizing antibodies, we are sharing more information about our response to this confidential inspection, given global interest in our treatment development efforts.

October 14, 2020

Today, Lilly shared a statement on the National Institute of Allergy and Infectious Diseases (NIAID) decision to pause enrollment in the ACTIV-3 clinical trial. ACTIV-3 is an independent study in hospitalized patients, sponsored by the National Institutes of Health (NIH).

October 13, 2020

Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent Data Safety Monitoring Board (DSMB) has recommended a pause in enrollment. The trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.

October 8, 2020

Lilly and Incyte are sharing additional data showing reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection requiring oxygen. This is 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).

Also today, Lilly announced our participation with the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, in a new global effort to ensure equitable access to COVID-19 therapeutic options for patients in low- and middle-income countries.

October 7, 2020

Today, Lilly announced additional details on our COVID-19 neutralizing antibody programs, including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19. Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy of two of Lilly’s SARS-CoV-2 neutralizing antibodies – LY-CoV55 and LY-CoV016 – reduced viral load, symptoms, and COVID-related hospitalization and ER visits.

Based on this combination therapy data and previous data, Lilly has submitted an initial request for emergency use authorization to the FDA for LY-CoV555 in higher-risk patients recently diagnosed with mild-to-moderate COVID-19. Lilly plans to make these therapies broadly available to patients.

“We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available,” said Dan Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.

Take a closer look at what it takes to get a neutralizing antibody from the lab to a manufacturing site and, finally, to patients.

September 30, 2020

Alongside 15 life-science industry peers and the Bill & Melinda Gates Foundation, Lilly joined in collectively committing to expand global access for COVID-19 medicines. Working together, we will stem the tide of the virus – and end this pandemic.

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September 18, 2020

Anne White, Lilly Oncology president, shared her perspective in a new op-ed column for STAT News regarding the necessity of a quick response within the health-care research ecosystem during the time of COVID-19. She provided three lessons to accelerate medical innovation while fighting a worldwide pandemic: more collaboration, rethinking clinical trial design and better integrating digital technologies.

September 17, 2020

Lilly and Amgen announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination.

September 16, 2020

Today, Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups. Learn more about these data, and view Lilly's Neutralizing Antibodies and COVID-19 fact sheet.

Also today: Lilly's chief scientific officer Dan Skovronsky, M.D., Ph.D., joined CNN chief medical correspondent Dr. Sanjay Gupta, National Institute of Allergy and Infectious Diseases (NIAID) director Dr. Anthony Fauci, and other members of the health care community for a panel discussion on racial disparities in clinical trials and Lilly's COVID-19 work. Watch video of this event, part of the Congressional Hispanic Caucus Institute's 2020 Leadership Conference, on CHCI's YouTube channel.

September 14, 2020

Lilly and Incyte 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. The study also met a key secondary endpoint.

August 3, 2020

Lilly announced today the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555, the lead antibody from our collaboration with AbCellera, for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S., including skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities.

In just 30 days, Lilly employees – with help from two Indiana-based companies – transformed an RV into a “clinical research unit on wheels” to reach elderly patients.

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July 20, 2020

Our ongoing work in the fight against COVID-19 includes putting our scientific R&D expertise front and center. Learn how we're battling the virus while keeping our employees safe in this new Wall Street Journal video.

Greater diversity in clinical trials ensures COVID-19 help the diverse populations most at risk. That's why it's crucial to reduce barriers to entry and include more minorities in research. Read more in this Politico op-ed column by Tim Garnett, M.D., Lilly's chief medical officer, and Joy Fitzgerald, chief diversity and inclusion officer, about what pharmaceutical companies should be doing to increase clinical trial diversity.

July 7, 2020

In partnership with hc1, a bioinformatics leader in precision testing and prescribing, Lilly's COVID-19 Drive-through Testing Dashboard was made available today. Key findings about COVID-19 patients are included, based on drive-through results and survey data gathered between April 6 and May 22 at our free testing site. This dashboard highlights pandemic trends in Central Indiana among health care workers, first responders, on-site essential workers and people deemed at higher risk for complications from the virus. These are the most comprehensive COVID-19 analytics available for the Central Indiana community to date.

June 16, 2020

Clinical investigators, hospitals or clinical sites interested in participating as an investigator or site in one of Lilly’s clinical trials for a potential COVID-19 treatment should call 1-800-CT-LILLY (1-800-285-4559) or email COVID19PotentialSite@Lilly.com.

Patients interested in participating in one of our clinical trials for a potential COVID-19 treatment should visit Lilly TrialGuide for information regarding eligibility for ongoing trials.

June 15, 2020

Lilly announced today that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of one of our medicines in hospitalized adults with COVID-19. The study includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.

June 8, 2020

Today we announced, with partner Junshi Biosciences, the start of a Phase 1 study for our second potential antibody treatment designed to fight COVID-19.

June 1, 2020

Today we announced patients have been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19. This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.

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Lilly scientists deliver our potential COVID-19 antibody treatment to Indianapolis International Airport

May 12, 2020

The Central Indiana COVID-19 Community Economic Relief Fund (C-CERF) made a third wave of grants totaling $4 million to 56 community organizations across Marion County. A coalition of funders, including the Lilly Foundation, established this fund in March. Combined with two earlier waves of grants, the fund has distributed more than $15.8 million to 100 organizations in Central Indiana.

May 5, 2020

As we begin to reopen our communities, we must proceed gradually, making decisions based on data and medical expertise, Lilly CEO Dave Ricks writes in The Indianapolis Star. Our fight against COVID-19 isn’t over yet; we have merely stalled its exponential growth.

May 4, 2020

Today, Lilly announced an agreement with Shanghai-based Junshi Biosciences to co-develop antibody therapies for the potential prevention and treatment of COVID-19.

April 27, 2020

The Indianapolis E-Learning Fund, which the Lilly Foundation helped launch earlier this month, announced the distribution of $1.5 million to schools across Marion County to invest in critical device and internet connectivity solutions for students and families. Here’s more information about the fund.

April 17, 2020

As this pandemic calls for a coordinated international research response, the National Institutes of Health in the U.S. will launch a public-private partnership with over 12 government agencies and pharmaceutical companies, including Lilly, to help accelerate research into COVID-19 treatments and vaccines.

April 10, 2020

Lilly announced today that we're teaming up with the National Institute of Allergy and Infectious Disease (NIAID), part of The National Institutes of Health, in the fight against the COVID-19 pandemic. One of our medicines will be studied as an arm in NIAID’s Adaptive COVID-19 Treatment Trial to investigate its efficacy and safety as a potential treatment for hospitalized patients diagnosed with COVID-19.

April 8, 2020

A collaborative of local stakeholders, including the Lilly Foundation, has established the Indianapolis E-Learning Fund with an initial investment of more than $2.6 million to support Indianapolis educators, students and families during the transition to e-learning in response to the recent COVID-19 public health emergency. Here's more information.

Also today, the Central Indiana COVID-19 Community Economic Relief Fund made unrestricted grants totaling $4.55 million to 32 community organizations across several counties in Central Indiana. Combined with the first round of grants made in March, this Central Indiana relief fund has distributed more than $11.8 million to 74 organizations to date. Read the press release.

April 7, 2020

With stress on our economy due to the COVID-19 crisis, we know many people may struggle now more than ever to pay for their medicines. So today, Lilly announced anyone who has commercial insurance, or no insurance, can purchase their monthly prescription of Lilly insulin for $35 through the Lilly Insulin Value Program. Learn more about the Lilly Diabetes Solution Center.

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COVID-19 drive-through testing at Lilly Corporate Center, Indianapolis

April 1, 2020

Lilly is expanding drive-through testing for COVID-19 to two additional groups of higher-risk individuals,

  • workers in businesses deemed essential by the State of Indiana who have regular public contact as part of their job, and

  • people in our community showing symptoms who are vulnerable to severe complications of the virus.

Lilly will continue to offer testing to eligible health care workers and first responders, and will continue to support the Indiana State Department of Health (ISDH) through laboratory testing of samples obtained in hospitals. To read eligibility requirements and find out how to register for testing, view Lilly's COVID-19 Testing website.

Also announced today: As we help combat COVID-19 in our home state, we feel a special responsibility to bring our community together to practice proven and effective health strategies, as our business is rooted in science. We’re proud to join #INThisTogether, a new coalition to help Indiana flatten the curve and slow the spread of COVID-19. Visit INThisTogetherCampaign.com for social distancing tips and to get involved.

Separately, in industry news today, Merck, Pfizer and Lilly announced medical service volunteer programs to enable employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay. This new effort is one of the many ways that America’s biopharmaceutical companies are coming together to fight COVID-19. Learn more here.

March 30, 2020

Lilly CEO Dave Ricks writes, "Our country is facing an unprecedented challenge with COVID-19. Already, the lives of far too many Americans have been disrupted. And for people who use insulin to manage their diabetes, a sudden loss of income can make affordability a problem. No one should go without their insulin, and we have meaningful solutions to help people get the medicine they need." Read his full letter and see how the Lilly Diabetes Solution Center can help you.

March 26, 2020

As the global situation evolves, we will continue to take the steps necessary to safeguard the reliable supply of our medicines. Lilly has a global monitoring system that allows us to be in the best position to determine the necessary supply of medicines to meet our obligation to patients and health care providers in each country. For that reason, we will not honor requests to stockpile or hoard our medications, whether for profit or due to a sense of concern. Unnecessary stockpiling of medication can create unintended shortages and puts other patients’ health at risk. We will consider emergency requests on a case-by-case basis, and we have created a special rapid response unit for expedited consideration of these requests. Read our full statement.

Globally, Lilly has joined a cross-industry collaboration and the Bill & Melinda Gates Foundation to accelerate the development, manufacturing and delivery of vaccines, diagnostics and treatments for COVID-19. This consortium of 17 life sciences companies will work collectively with national regulators and the World Health Organization to ensure promising studies are quickly scaled to help people around the world.

Also, 46 community organizations received immediate grants totaling  $7.3 million from the Central Indiana COVID-19 Community Economic Relief Fund. A coalition of funders, including the Lilly Foundation, established the fund to support human services organizations in Central Indiana that serve people affected by the evolving crisis. Additional waves  of funding are planned.

March 24, 2020

As announced on March 3, Lilly does not currently anticipate shortages for any of our medicines, including all forms of insulin. A large network of global external manufacturing partners helps us supply medication to nearly 125 countries. Since the initial outbreak, we have closely monitored our supply chain for potential impact and continue to do so. Our insulin manufacturing sites in the U.S. and Europe remain operational, with increased precautions in place to protect the supply and the welfare of our employees. Read more here.

U.S. pharmacies that temporarily don't have Lilly medicines in stock due to higher demand can order them from wholesalers, generally delivered in one to two days. Lilly has received a few reports of U.S. pharmacies stating that insulin orders are not being fulfilled due to "manufacturer backorder." Lilly has informed wholesalers and others in the supply chain that we do not have any products on backorder, including insulin. Patients should ask their pharmacist to secure an order from their wholesaler. Here's more information.

March 23, 2020

Lilly will expand drive-through testing for the virus that causes COVID-19 to Central Indiana first responders beginning March 24. (Note: This has since been expanded to additional groups of people.) The additional group eligible for testing includes first-line responders such as public safety, fire and ambulance public servants. View the COVID-19 testing site here. Testing of this group will be determined and directed by individual public safety agencies’ occupational health provider in conjunction with the Emergency Operations Center safety officer to ensure the criteria for testing is met. First-line responders should begin contacting their line management starting March 24 to receive further instructions.

Lilly also provided an update on the company's clinical trial activities in light of the COVID-19 pandemic. We will delay most new study starts and pause enrollment in most ongoing studies, while continuing ongoing clinical trials for patients already enrolled. Here's more information.

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A Lilly colleague works the COVID-19 testing hotline for health care workers

March 22, 2020

Lilly announced that the company will offer drive-through testing for the virus that causes COVID-19 to Indianapolis-area health care workers. That begins the next day, March 23, as a service to the community and in an effort to protect health care providers working on the front lines during this epidemic. View the COVID-19 testing site here. Active health care workers are eligible, and must have a physician’s order requesting testing for COVID-19. There will be no charge for this service.

March 18, 2020

As announced today, Lilly scientists are partnering with the Indiana State Department of Health (ISDH), with support from the U.S. Food and Drug Administration (FDA), to accelerate testing in Indiana for SARS-CoV-2, the virus that causes COVID-19.

We will use our specialized research laboratories to analyze samples taken in Indiana health care facilities, including nursing homes and emergency rooms. This should start to expand Indiana's ability to conduct testing and receive a timely diagnosis of individuals who suspect they may be carrying the virus. As Lilly's testing capacity expands, Lilly and ISDH will work together to maximize the impact of broader testing.

March 13, 2020

The Lilly Foundation contributed $500,000 to United Way of Central Indiana’s Community Economic Relief Fund. The fund will support human services organizations and the individuals and families they serve who are affected directly or indirectly by the COVID-19 virus. The Lilly Foundation is also providing a 2:1 match for Lilly employee and retiree contributions to the fund.

March 12, 2020

Lilly and AbCellera agreed to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera's rapid pandemic response platform and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. 

March 9, 2020

Our Employees and Their Families

Our guiding principles are to protect the health and safety of our employees, and to protect our ability to make and supply medicines to patients.

To reduce the risk of virus transmission, we’re taking measures to maximize “social distancing” by asking employees at Lilly’s United States facilities to work from home if possible, and by restricting travel within the U.S.

We have a unique responsibility to ensure continuity in our manufacturing facilities and R&D labs. By minimizing staff in our offices, we are reducing risk of inadvertent transmission to workers who don’t have the option of continuing to do their important work from home.

February 3, 2020

Relief Efforts

Lilly China made a cash donation of one million yuan (approximately US$150,000) to the Red Cross, and the Lilly Foundation donated an additional $100,000 to Direct Relief, a U.S. non-profit organization. Direct Relief has made multiple airlift shipments of personal protective equipment and supplies into China. The Lilly Foundation also made a $150,000 donation to Project HOPE, a U.S.-based non-governmental organization (NGO) that, as shown below, is active in disaster response areas.

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Courtesy Project HOPE