FDA approved Novartis Cosentyx and Lilly’s Taltz for nr-axSpA in June
FDA approved Eli Lilly’s Taltz on June 1st, 2020
FDA approved Novartis Cosentyx on June 17th, 2020
Taltz and Cosentyx are IL-17 inhibitors
Cosentyx showed 38% improvement in ASAS40 at week 52, Taltz showed improvement in 30% of patients
Novartis has announced that it has received the approval of Cosentyx (secukinumab) for treatment of non-radiographic axial spondyloarthritis.
The approval is based on Phase 3 PREVENT study, which included 555 adult patients with non-radiographic axial spondyloarthritis. Both treatment naïve and patients who had an inadequate response or who are intolerant to anti-tumor necrosis factor-α therapy (anti-TNFs) were included in the trial. Cosentyx has achieved statistically significant improvement versus placebo in improving the signs and symptoms 0f nr-axSpA, Assessment of Spondyloarthritis International Society (ASAS40) at week 52 was considered as the primary endpoint. ASAS40 responses at week 52 in Cosentyx arm without load and with load are 38% and 34% respectively.
Patients treated with Cosentyx had improved health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire in week 16. The Short Form health survey (SF-36) was used to measure the quality of life. After 16 weeks of treatment with Cosentyx, patients had improvement in SF-36 and mental component summary (MCS) score.
On June 1st, the US FDA has approved Taltz, another IL-17 inhibitor for the same indication. The drug has been approved based on Phase 3 COAST-X trial, which evaluated the efficacy of Taltz versus placebo. ASAS40 was considered as the primary endpoint. After 16 weeks of treatment with Taltz, 35% of patients treated with Taltz every four weeks achieved ASAS40 response, and 40% of patients treated with Taltz every two weeks achieved the response compared to 19% of patients who were on placebo. After 52 weeks of treatment with Taltz, 30% of patients treated with Taltz every four weeks, and 31% of patients treated with Taltz every two weeks achieved ASAS40 response compared to 13% of patients who were treated with placebo.
The US FDA has approved Cosentyx (secukinumab) for plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and active non-radiographic axial spondyloarthritis.
The drug is in different phases for other indications.
Registration: Pediatric plaque psoriasis
Phase 3: Lupus nephritis
Phase 2: Giant cell arteritis, Lichen planus
Taltz (ixekizumab) is an IL-17 inhibitor; prior approved for plaque psoriasis, ankylosing spondylitis, pediatric plaque psoriasis, and non-radiographic axial spondyloarthritis.
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