FDA approves new indication for Eli Lilly’s Taltz

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FDA approves new indication for Eli Lilly’s Taltz

By Sandra Levy - 08/29/2019
Eli Lilly has received the Food and Drug Administration’s blessing for Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis, or AS, also known as radiographic axial spondyloarthritis.

This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.

"Ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility," said Rebecca Morison, vice president, U.S. Immunology at Lilly. "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."

"Having new treatment options for the ankylosing spondylitis community is truly encouraging," Spondylitis Association of America CEO Cassie Shafer said. "The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure."

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