EMA Recommends Brodalumab for Approval

May 22, 2017

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.

On May 19, 2017, AstraZeneca announced that its 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 a fully human monoclonal antibody that selectively targets the IL-17 receptor. By binding to the receptor, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines.

In July 2016, AstraZeneca announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights to develop and commercialize brodalumab in Europe. The CHMP recommendation follows the approval of brodalumab by FDA (brand name Siliq) in February 2017 and the approval by the Japanese Pharmaceuticals and Medical Devices Agency, in 2016.

Siliq comes with a boxed warning for a potential link to suicidal ideation. In 2015, Amgen dropped out of co-developing the drug with AstraZeneca when it became clear patients were demonstrating thoughts of suicide.

Source: AstraZeneca