RELATED: Novel Psoriasis Drug Recommended by FDA Advisory Group. This approval was based on the safety and efficacy outcomes from 10 Phase 2 and 3 studies that included over 3,990 patients with moderate to severe plaque psoriasis. I am an Analyst for Datamonitor Healthcare based in our New York office. Janssen’s Stelara (ustekinumab), a fully human monoclonal antibody that targets the p40 subunit of cytokines interleukin (IL)-12 and IL-23 proteins, was the first drug in its class to be approved for moderate to severe plaque psoriasis, and has subsequently garnered increasing market share at both first and second line. The drug’s superior efficacy to Enbrel has already been demonstrated in a head-to-head clinical trial (as part of the ACCEPT program). 17, biosimilars, narcotics, the ACR and gout? Our year end review discusses the most impactful news and research from the last 12 months. Psoriatic Therapies Take Off: After a few years of research reports and increasing awareness of the Th17 axis and IL-17 as a mediator of inflammation in select disorders, we now have FDA approval forsecukinumab (Cosentyx) to treat psoriasis. FDA (link is external) in February for moderate to severe plaque psoriasis.
Cosentyx For Plaque Psoriasis Approved