Lilly bags Taltz FDA approval for ankylosing spondylitis

August 28, 2019 | Filed under: Pharma Regulatory News | Posted by: pharmanewsdaily Tags: ankylosing spondylitis, Eli Lilly and Company, FDA, ixekizumab, radiographic axial spondyloarthritis, Rebecca Morison, Taltz, US Food and Drug Administration, USA

Taltz FDA approval : The US Food and Drug Administration (FDA) has approved US pharma giant Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults having active ankylosing spondylitis (AS).

Also known as radiographic axial spondyloarthritis (r-axSpA), ankylosing spondylitis is a type of spondyloarthritis that affects the pelvic joints and spine. Symptoms of ankylosing spondylitis include chronic inflammatory back pain, stiffness, and damaged function and mobility.

Taltz has the ability to preferentially bind with interleukin 17A (IL-17A) cytokine and prevent its interaction with the IL-17 receptor, a naturally occurring cytokine involved in normal inflammatory and immune responses. Taltz blocks the release of pro-inflammatory cytokines and chemokines.

The latest Taltz FDA approval marks the third for the Lilly monoclonal antibody. It was first approved about three years ago for the treatment of moderate to severe plaque psoriasis in adults. About a year later, Lilly bagged the second Taltz FDA approval for the treatment of active psoriatic arthritis in adults.

Lilly gets Taltz FDA approval for ankylosing spondylitis. Photo courtesy of Guanaco152003/Wikipedia.org.

Basis of Taltz FDA approval for ankylosing spondylitis

The third FDA approval for Taltz has been driven by the efficacy and safety data it registered from a couple of phase 3 trials, which involved 657 adult patients having ankylosing spondylitis.

The two late-stage trials, as part of the COAST clinical trial program, showed that patients on Taltz treatment experienced statistically significant and clinically meaningful improvements in their signs and symptoms, as per the Assessment of Spondyloarthritis International Society 40 (ASAS40) response, in comparison to placebo.

Also, patients in the Taltz arm had statistically significant improvements for all the major secondary endpoints in the two phase 3 trials in ankylosing spondylitis.

Commenting on the latest Taltz FDA approval, Rebecca Morison – Lilly US Immunology vice president, said: “Ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility.

“We are excited to now offer Taltz as a treatment option for people in need of relief from the symptoms of AS. This approval further underscores Lilly’s commitment to helping people living with rheumatic diseases.”

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