FDA Accepts Valeant-AstraZeneca Psoriasis Application
The US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) submitted by UK-Swedish drugmaker AstraZeneca in partnership with Canadian drugs firm Valeant Pharmaceuticals for the psoriasis treatment, brodalumab.
The therapy is a monoclonal antibody that targets the IL-17 receptor in patients suffering with moderate to severe psoriasis. The skin condition is a long-lasting autoimmune disease, characterized by patches of abnormal skin which are typically red, scaly and itchy.
BLA is supported by data from three Phase III studies which have shown that the drug candidate was effective in totally clearing the disease in a significant number of patients, and was also superior to ustekinumab, a leading approved psoriasis treatment.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Nov. 16, 2016. The European Medicines Agency (EMA) accepted the application for marketing approval in the final quarter of 2015.
In October of last year, AstraZeneca awarded Valeant an exclusive license to develop and commercialize brodalumab worldwide, excluding Japan and certain other (undisclosed) Asian countries where rights are held by Kyowa Hakko Kirin.
