AMAGINE-2 and AMAGINE-3 studies of brodalumab in psoriasis shown superior to Stelara (ustekinumab) and published in NEJM- Valeant Pharma
The New England Journal of Medicine (NEJM) has published positive results from two pivotal, multi-centre, Phase III studies – AMAGINE-2 and AMAGINE-3 – demonstrating that treatment with brodalumab resulted in significant clinical improvements in patients with moderate to severe psoriasis and was superior to both placebo and ustekinumab, a leading approved treatment for psoriasis. Brodalumab, a fully human monoclonal antibody, is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F, A/F and C) to the receptor.
The studies were funded by AstraZeneca and Amgen, the former sponsor of the brodalumab programme. AstraZeneca recently announced it has entered into a collaboration with Valeant Pharmaceuticals, granting Valeant an exclusive license to develop and commercialise brodalumab. Regulatory submissions in the United States and European Union for brodalumab in moderate to severe psoriasis are planned for the fourth quarter of 2015.