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OLUMIANT (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis

INDIANAPOLIS, Jan. 28, 2022. Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) today announced updates on the Phase 3 development program for OLUMIANT (baricitinib) in adults with active systemic lupus erythematosus (also referred to as SLE and lupus) and the status of the U.S. atopic dermatitis supplemental new drug application (sNDA).

Lupus program update
Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus.

In SLE-BRAVE-I, the baricitinib 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity as measured by the proportion of adults with active lupus who achieved an SRI-4 response (a composite measurement of overall disease activity) at Week 52 compared to placebo. The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of SRI-4 response. Key secondary endpoints were not met in either study. Safety findings from both lupus studies were consistent with previously published OLUMIANT data and did not impact our decision to discontinue the program. Lilly intends to analyze the totality of our lupus data to help inform our understanding of the disease and advance the science and intends to publish findings at a later date.

Lilly is working with investigators to appropriately conclude the Phase 3 SLE long-term extension trial, SLE-BRAVE-X, which was designed to evaluate the long-term safety and efficacy of OLUMIANT over three years in adults who completed SLE-BRAVE-I or II.

Atopic dermatitis regulatory update
Lilly is in ongoing discussion with the U.S. Food and Drug Administration (FDA) regarding the status of the sNDA for OLUMIANT for the treatment of adults with moderate-to-severe atopic dermatitis. At this point, the company does not have alignment with the FDA on the indicated population. Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter (CRL). The efficacy and safety profile of OLUMIANT was evaluated in eight atopic dermatitis clinical trials (six double-blind, randomized, placebo-controlled studies and two long-term extension studies) inclusive of patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The safety profile in these trials was consistent with previously published OLUMIANT data.

OLUMIANT was the first JAK inhibitor approved to treat moderate-to-severe patients with atopic dermatitis who have an inadequate response to topical treatments in the European Union and Japan.

"On behalf of all of us at Lilly, we thank the participants, trial sites and clinical investigators for their essential contributions to the OLUMIANT atopic dermatitis and lupus programs. We are disappointed for the millions of people who suffer from these complex and hard-to-treat autoimmune diseases and are in need of more treatment options, and we remain committed to pursuing treatment advances in immunology that can make life better for people around the world," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly. "These decisions do not affect Lilly's other research efforts for OLUMIANT or its approved indications. We are confident in OLUMIANT for approved indications in the U.S. and globally as OLUMIANT has one of the largest and longest sets of available safety data in the JAK inhibitor class, including nine years across the clinical development program."

"This year, we are eager to provide OLUMIANT to more patients in therapeutic areas where there is significant unmet medical need," Mallbris said. "We look forward to potential regulatory approvals for OLUMIANT in 2022, including COVID-19 for certain hospitalized patients in the U.S. and severe alopecia areata in the U.S., European Union and Japan, where OLUMIANT has the potential to be a first-in-disease treatment."

More than 325,000 people worldwide have been treated with OLUMIANT to date across approved indications. On January 13, 2022, the World Health Organization (WHO) released new guidelines on treatments for COVID-19, strongly recommending the use of baricitinib in combination with corticosteroids for severely or critically ill patients. To read Lilly's statement about the WHO COVID-19 guidelines update, click here. Baricitinib is approved or authorized for emergency use for treatment of certain hospitalized patients with COVID-19 in 14 countries. To date, more than 740,000 patients globally are estimated to have been treated with baricitinib for COVID-19. In the U.S., baricitinib is authorized by the FDA for emergency use in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The FDA has granted priority review for the sNDA for baricitinib for the treatment of certain hospitalized patients with COVID-19, with an anticipated regulatory action in Q2 2022.

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) for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or 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 declaration is terminated or authorization revoked sooner.

About OLUMIANT

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 is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. To date, more than 325,000 patients have been treated with OLUMIANT worldwide across approved indications. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for OLUMIANT in multiple countries. The U.S. FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here. OLUMIANT is also being investigated in alopecia areata (AA) and juvenile idiopathic arthritis (JIA).

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of OLUMIANT 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.

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.

OLUMIANT is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Lilly Forward-Looking Statement

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 treatment for patients with rheumatoid arthritis and other approved indications and potential treatment for patients with systematic lupus erythematosus and other conditions and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug 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, and that OLUMIANT will receive additional regulatory approvals, or be commercially successful. 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.


SOURCE Eli Lilly and Company

Posted: January 2022

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