08.27.19
Eli Lilly and Co. received approval from U.S. FDA for Taltz® injection 80 mg/mL for the treatment of adult with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).
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, and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.
The efficacy and safety of Taltz in AS was demonstrated in two Phase 3 studies where results from both studies demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared to placebo. Overall, the safety profile observed in patients with AS treated with Taltz is consistent with the safety profile in patients with psoriasis.
"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."
"Results from the Phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors," said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington. "This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS."
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, and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.
The efficacy and safety of Taltz in AS was demonstrated in two Phase 3 studies where results from both studies demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared to placebo. Overall, the safety profile observed in patients with AS treated with Taltz is consistent with the safety profile in patients with psoriasis.
"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."
"Results from the Phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors," said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington. "This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS."
