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Eli Lilly Says FDA OKs SBLA For Taltz Injection For Non-Radiographic Axial Spondyloarthritis

Eli Lilly and Co. (LLY) announced Monday that 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.

This approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA.

Axial spondyloarthritis (axSpA), which includes both ankylosing spondylitis (AS) and nr-axSpA, is a disease predominantly affecting the sacroiliac joints and the spine, resulting in chronic inflammatory back pain and fatigue.

It is estimated that 2.3 million people in the U.S. have axSpA, and approximately half of those individuals live with nr-axSpA.

This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria compared to placebo. ASAS40 measures disease signs and symptoms such as pain, inflammation and function.

Taltz is already 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.

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 plaque psoriasis, psoriatic arthritis, AS and nr-axSpA.

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