Lilly Announces Positive Top-Line Results for Second Phase 3 Study of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) for TNF Inhibitor-Experienced Patients
Lilly Announces Positive Top-Line Results for Second Phase 3 Study of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) for TNF Inhibitor-Experienced Patients |
[28-June-2018] |
INDIANAPOLIS, June 28, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first AS study focusing on a difficult-to-treat population of patients who had an inadequate response to one or two tumor necrosis factor (TNF) inhibitors (90 percent of enrolled patients) or intolerance to a TNF inhibitor (10 percent). Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. COAST-W is part of the clinical development program for Taltz in AS, the first to use ASAS40 across the program as the primary endpoint to define treatment success, rather than the traditionally used endpoint of ASAS20. AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterized by chronic inflammatory back pain, stiffness and impaired function and mobility.1 Of those affected by AS, approximately 80 percent will experience symptoms before age 30.2 "These positive results, in combination with previous results from the Phase 3 COAST-V study, provide further support for Taltz as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population," said Dr. Lotus Mallbris, vice president, Immunology Development. "By using ASAS40 as the primary endpoint in our clinical development program, we hope to establish a higher treatment target goal for AS patients. We look forward to sharing additional clinically meaningful data from this study, and remain committed to continuing our research to evaluate potential treatment options that deliver better outcomes for patients living with this disease." In COAST-W, the incidence of serious adverse events was similar with Taltz compared with placebo. The most common adverse events observed were consistent with other Phase 3 studies of ixekizumab. Lilly plans to submit detailed data from COAST-W for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on the positive results from the COAST-V and COAST-W studies, the company plans to submit for U.S. regulatory approval in AS later this year. Indications and Usage IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Pre-Treatment Evaluation for Tuberculosis Hypersensitivity Inflammatory Bowel Disease Immunizations ADVERSE REACTIONS Please click to access the Prescribing Information and Medication Guide. Please click to access Instructions for Use included with the device. About the COAST-W Study About the Taltz Program in axSpA About Taltz® About Eli Lilly and Company This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a potential treatment for Ankylosing Spondylitis, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. 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. 1 Spondyloarthritis. American College of Rheumatology website. http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis. Accessed May 4, 2018.
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