AstraZeneca’s partner LEO Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of brodalumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Brodalumab is the first and only fully human monoclonal antibody that selectively targets the IL-17 receptor. By binding to the receptor, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis, a chronic, debilitating skin disease that causes red patches of skin covered with silvery scales.
In July 2016, AstraZeneca signed an agreement with dermatology specialist LEO Pharma, granting the company exclusive rights to develop and commercialise brodalumab in Europe.
This latest announcement follows the approval of brodalumab by the US Food and Drug Administration (FDA), with the brand name Siliq, in February 2017 and the approval by the Japanese Pharmaceuticals and Medical Devices Agency, in 2016.
The CHMP’s positive opinion on brodalumab will now be reviewed by the European Commission, which approves medicines for use in the European Union. The final decision is applicable to all EU and European Economic Area countries (Iceland, Liechtenstein and Norway).