Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab)
Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, today's approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA.
Axial spondyloarthritis (axSpA), which includes both AS and nr-axSpA, is a disease predominantly affecting the sacroiliac joints and the spine, resulting in chronic inflammatory back pain and fatigue.1,2,3 It is estimated that 2.3 million people in the U.S. have axSpA, and approximately half of those individuals live with nr-axSpA.2,4 For patients with AS, the disease is characterized by the presence of structural damage of the sacroiliac joints that appears on an X-ray, while patients with nr-axSpA do not have clearly detectable structural damage radiographically.5 These two patient subsets share a similar burden of disease and similar clinical features, but approved biologic treatment options for patients with nr-axSpA are much more limited and patients are often underdiagnosed.5,6
Other major secondary endpoints of the study included Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), the proportion of patients achieving low disease activity (ASDAS <2.1) and the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score.
An estimated 137,000 patients have been treated with Taltz worldwide since launch, with
approximately 80,000 of those in the U.S., giving rheumatologists confidence in
making informed prescribing decisions for patients with PsO, PsA, AS and
nr-axSpA.7
Lilly will work with insurers, health systems and providers to ensure patients are able to access this treatment. We recognize that COVID-19 may be impacting the ability for people to afford their medications, and the Taltz TogetherTM program helps ensure patients pay the lowest amount possible and can have Taltz delivered straight to their homes. Patients, physicians, pharmacists or other healthcare professionals with questions about Taltz should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com. If you'd like to learn more about insurance support, call at 1-844-TALTZ-NOW (1-844-825-8966) or visit www.taltz.com/patient-support.
INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, active psoriatic arthritis, or active ankylosing spondylitis, and for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.