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Lilly Says Phase 3 Study Of Taltz Meets Primary & All Major Secondary Endpoints

Eli Lilly and Co. (LLY) said that a Phase 3 Study of Taltz in Patients with Non-Radiographic Axial Spondyloarthritis met the primary and all major secondary endpoints in COAST-X.

Lilly has submitted for U.S. regulatory approval for adults with active non-radiographic axial spondyloarthritis, based on these positive results.

COAST-X is a 52-week placebo-controlled Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the spine skeleton and is estimated to affect 4.5 million adults worldwide.

Taltz also met the major secondary endpoints in the study at Week 16 and Week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity.

Taltz is approved for the treatment of adults with adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.

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