AMG 827 (brodalumab) filed with FDA for plaque psoriasis- AstraZeneca/Valeant
The FDA has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for AMG 827 (brodalumab injection), 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted 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. 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.
Comment: The drug was filed with the EMA in Q4 2015.
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