Data from ACTT-2 trial of baricitinib in hospitalized COVID-19 patients supportive of the U. S. FDA EUA published in New England Journal of Medicine
TORONTO, Dec. 19, 2020 – On December 11, 2020, Eli Lilly and Company and Incyte announced that The New England Journal of Medicine published peer-reviewed results 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). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19, 2020 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen.
“We are pleased to learn about baricitinib’s role in improving clinical outcomes for patients with moderate- to severe symptoms of COVID-19. These high-quality research data published in The New England Journal of Medicine will help healthcare providers better understand potential COVID-19 treatment options,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. “Lilly continues to work closely with our medical and scientific community to find solutions to end this pandemic.”
Read the full NIAID press release on ACTT-2 results here.
Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. In Canada, baricitinib has not been approved by Health Canada to treat COVID-19, and the efficacy, safety, and optimal duration of treatment of baricitinib for COVID-19 has not been established.
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.
OLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT may be used as monotherapy in cases of intolerance to MTX.<sup>1</sup>
OLUMIANT is believed to interfere with the activity of an enzyme called Janus Kinase (JAK) involved in immune system regulation.
About Eli Lilly Canada
Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA.
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.
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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 as a treatment for patients with rheumatoid arthritis and other conditions, as well as its supply, and reflects Lilly’s and Incyte’s current beliefs and expectations. However, as with any such undertaking there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or authorizations or be commercially successful, that we can provide an adequate supply of OLUMIANT in all circumstances, or that OLUMIANT will be safe and effective as a treatment for COVID-19. 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.
OLUMIANT Product Monograph