FDA Accepts AstraZeneca/Valeant BLA for Psoriasis Therapy

FDA has accepted for review an AstraZeneca and Valeant Pharmaceuticals BLA for brodalumab injection, a monoclonal antibody that targets the IL-17 receptor for treating patients with moderate-to-severe plaque psoriasis. The agency has set a user fee review target date of 11/16.

The submission is supported by data from the three AMAGINE Phase 3 pivotal studies. The results showed that brodalumab has an “effective mechanism of action that could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease,” according to the companies. “At the 210 mg dose, brodalumab was shown to be effective in total skin clearance of psoriasis compared to placebo and superior to ustekinumab, a leading approved psoriasis treatment, at week 12 in two replicate comparator trials involving over 3,500 patients.”