- A Phase 3 clinical trial, COAST-V, evaluating Eli Lilly's (NYSE:LLY) Taltz (ixekizumab) for the treatment of ankylosing spondylitis (AS) met the primary and all key secondary endpoints.
- Taltz demonstrated a statistically significant improvement in AS symptoms as measured by the proportion of patients who achieved ASAS40 at week 16. ASAS40 means that AS patients improved at least 40% in three of four domains (patient global, pain, function and inflammation). This is a higher bar since the historical metric has been ASAS20 (20% improvement in three of four domains).
- The study included a placebo arm and an active control arm [AbbVie's Humira (adalimumab)] for comparison to placebo. It also evaluated patients who had never received a biologic disease-modifying anti-rheumatic drug.
- Detailed results will be submitted for presentation at future scientific conferences and for publication.
- Regulatory submissions are on tap for later this year pending additional data from the ongoing development program.
- The FDA approved Taltz in December 2017 for psoriatic arthritis.
- Now read: Eli Lilly: Solid 2017, Soft Sales Guidance
Original article