Valeant, in partnership with AstraZeneca, announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for brodalumab injection for patients with moderate-to-severe plaque psoriasis.
The BLA application is based on data from three Phase 3 pivotal studies from the AMAGINE clinical program. Results highlighted the effectiveness of brodalumab 210mg in total skin clearance of psoriasis vs. placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016 for the BLA.
Brodalumab, a novel human monoclonal antibody, inhibits inflammatory signaling that may lead to inflammation by binding to the interleukin-17 (IL-17) receptor and blocking the binding of several types of IL-17 to the receptor.