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).
| INDIANAPOLIS, Jan. 28, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (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 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 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. For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see 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 Warnings Serious Infections: There is limited information regarding use of baricitinib in patients with COVID-19 and concomitant active 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: There is limited information regarding use of baricitinib in patients with COVID-19 and any of the following clinical findings: absolute neutrophil count (ANC) <1000 cells/mm3, absolute lymphocyte count (ALC) <200 cells/mm3, and hemoglobin <8g/dL. Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count 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. Vaccinations: Avoid use of live vaccines with baricitinib. 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 and Medication Guide 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. Adverse Reactions In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ≥ 1% of patients treated with baricitinib were alanine aminotransferase (ALT) ≥3 x upper limit of normal (ULN) (18.0%), aspartate aminotransferase (AST) ≥3 x ULN (11.5%), thrombocytosis >600,000 cells/mm3 (8.2%), creatine phosphokinase (CPK) >5 x ULN (3.7%), neutropenia <1000 cells/mm3 (2.2%), deep vein thrombosis (1.5%), pulmonary embolism (1.4%), and urinary tract infection (1.3%). 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. Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish). BC HCP EUA ISI 28JUL2021 About SLE-BRAVE-I and II Studies SLE-BRAVE-I and II were global, double-blind, multicenter studies evaluating the efficacy and safety of baricitinib 2-mg and 4-mg oral once-daily compared to placebo in adults with active lupus. The predefined primary endpoint for the studies was the proportion of participants achieving an SRI-4 response at Week 52. The SRI-4 response is a composite clinical endpoint used in lupus trials to measure response to treatment based on decrease in overall disease activity. More than 1,500 adults with active lupus were enrolled across studies, with all patients in the baricitinib and placebo treatment groups receiving standard of care background therapy. 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. 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) blockers. 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, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS
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. 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 localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of 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. Consider anti-TB therapy prior to initiation of 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. 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. MORTALITY Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant. MALIGNANCIES Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. MAJOR ADVERSE CARDIOVASCULAR EVENTS Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. THROMBOSIS GASTROINTESTINAL PERFORATIONS LABORATORY ABNORMALITIES 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 HYPERSENSITIVITY ADVERSE REACTIONS PREGNANCY AND LACTATION HEPATIC AND RENAL IMPAIRMENT Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide. BA HCP ISI 06DEC2021 About Lilly in Immunology About Eli Lilly and Company About Incyte OLUMIANT® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. P-LLY 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 | ||||||
Company Codes: NASDAQ-NMS:INCY, NYSE:LLY |
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