Posted by Michael Wonder on 20 Jun 2018
Novartis receives FDA approval for inclusion of new evidence that Cosentyx inhibits progression of joint structural damage in psoriatic arthritis
19 June 2018 - New prescribing information to include data demonstrating Cosentyx (secukinumab) slows progression of joint structural damage associated with psoriatic arthritis at Week 24.
Novartis announced today that the US FDA approved the inclusion of new evidence that Cosentyx (secukinumab) significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA). The data will be added to the drug's prescribing information and is effective in the US immediately. Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.
PsA can lead to reduced mobility and irreversible joint damage if left untreated. The update to the prescribing information is based on data from FUTURE 5, the largest Phase III study for a biologic done in PsA to date (996 patients).
