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Novartis today announced that AIN457 (secukinumab) met primary and key secondary endpoints in two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with ankylosing spondylitis (AS). Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A)[3], a protein that is central to the development of inflammatory diseases[4], including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress.
Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
Secukinumab showed an acceptable safety profile in both studies which was consistent with that observed in the large psoriasis clinical trial program, involving approximately 4,000 patients[8].
About secukinumab (AIN457) and interleukin-17A (IL-17A)
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively neutralizes the action of IL-17A[3]. Secukinumab is the first medicine selectively targeting IL-17A with positive Phase III results for the treatment of AS. IL-17A, a protein that stimulates inflammation, is central to the development of psoriasis and other inflammatory arthritic diseases, including AS[4].In addition to AS, secukinumab is also in clinical trials for the treatment of psoriasis arthritis (PsA) and rheumatoid arthritis (RA). Global regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with approvals anticipated in late 2014 or early 2015.
Via Krishan Maggon
AS is a painful, progressively debilitating condition associated with inflammation of the spine, causing irreversible consequences that significantly reduce patients' mobility and quality of life[1],[2]
Up to 40% of patients have an inadequate or no response to standard of care anti-TNF (tumor-necrosis-factor) medicines, currently the only biologic therapies available for patients with AS[1]
The secukinumab results in AS follow positive topline data in psoriatic arthritis (PsA) announced in September; joint regulatory filing of secukinumab in AS and PsA planned for 2015