- The FDA accepts for review the Biologics License Application (BLA) submitted by AstraZeneca (NASDAQ:AZN +0.8%), in partnership with Valeant Pharmaceuticals (VRX -0.5%), seeking clearance of brodalumab for the treatment of moderate-to-severe plaque psoriasis. The agency's action date (PDUFA) is November 16.
- Valeant has exclusive rights to develop and commercialize brodalumab worldwide, except in Japan and certain other Asian countries where Kyowa Hakko Kirin owns the rights. It acquired the rights after Amgen (AMGN +0.4%) backed out due to the potential adverse side effect increased suicidal thoughts.
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Brodalumab is a human monoclonal antibody that binds to interleukin-17 (IL-17), thus blocking its binding to its receptor and inhibiting inflammatory signaling.
- Previously: Valeant strikes psoriasis-drug deal with AstraZeneca (Sept. 1, 2015)
- Previously: Amgen terminates brodalumab co-development deal with AstraZeneca (May 22, 2015)