EMA Recommends Brodalumab for Approval
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
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
