Lilly’s hot-selling drug Taltz gets FDA approval for fifth use

Eli Lilly and Co. has won federal approval to market its hot-selling anti-inflammatory drug Taltz for another use: treatment of a type of arthritis that does not show any structural body damage on X-rays.

The Indianapolis-based drugmaker said Monday the Food and Drug Administration approved Taltz for the treatment of a condition called active non-radiographic axial spondyloarthritis in patients with objective signs of inflammation, such as redness, swelling or pain.

Axial spondyloarthritis is an umbrella term for types of inflammatory arthritis that primarily affect the spine and joints that connect the lower spine to the pelvis, often resulting in chronic inflammatory back pain and fatigue. Millions of Americans suffer from various forms of the disease.

This is the fifth approval for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis.

The FDA also approved Taltz for the treatment of adults with active psoriatic arthritis, for the treatment of adults with active axial spondyloarthritis, and for moderate to severe plaque psoriasis as young as six years old.

Taltz rang up sales of $1.3 billion last year, an increase of 46%, making it Lilly’s fastest-growing drug. An estimated 137,000 patients have been treated with Taltz worldwide since its launch four years ago.

Jami Rubin, a drug analyst at Goldman Sachs, has predicted that sales of Taltz could hit $2.5 billion a year by 2025. Some scientists and analysts say the opportunities for a drug like Taltz are vast, since it is potentially able to address many autoimmune diseases—conditions in which a patient’s immune system mistakenly attacks the body, trying to guard against bacteria and viruses.

Lilly said about 2.3 million people in the U.S. have axial spondyloarthritis, and approximately half of those individuals live with the non-radiographic form of the disease.

“We recognize that many patients living with this condition suffer from chronic inflammatory back pain and other symptoms of inflammation for years before being diagnosed, and we’re excited about the possibility of these patients finding relief with Taltz,” said Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines.

This approval is based on the results from a clinical trial that evaluated improvement in signs and symptoms of non-radiographic axial spondyloarthritis as measured by the proportion of patients who achieved certain criteria compared to placebo. The trial measured disease signs and symptoms such as pain, inflammation, and function.

The drug, which also is known by its generic name, ixekizumab, is administered by injection. It uses an antibody to inhibit a pro-inflammatory protein called interleukin 17.