AstraZeneca has received acceptance for review from the US Food and Drug Administration for its Biologics License Application for brodalumab injection, 210 mg. The injection is a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The application was submitted in collaboration with Valeant.

The US Food and Drug Administration has assigned a Prescription Drug User Fee Act action date of 16 November 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.

The Marketing Authorisation Application (MAA) for brodalumab in psoriasis was accepted by the European Medicines Agency (EMA) in fourth quarter of 2015. The two firms signed a collaboration agreement in October 2015. Under the agreement, Valeant has an exclusive license to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co Ltd.