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AstraZeneca today 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 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 announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights to develop and commercialise brodalumab in Europe. Today’s announcement follows the approval of brodalumab by the US Food and Drug Administration (FDA) (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 has the authority to approve medicines for the European Union (EU). The final decision is applicable to all EU and European Economic Area countries (Iceland, Liechtenstein and Norway).
NOTES TO EDITORS
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
The CHMP positive opinion is based on data from the three AMAGINE Phase III pivotal studies that demonstrated that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis with approximately twice as many patients on brodalumab achieving total skin clearance compared to ustekinumab at week 12 in two replicate comparator trials involving over 2,400 patients.
LEO Pharma has exclusive rights to develop and commercialise brodalumab in Europe.
Valeant Pharmaceuticals has the global exclusive licence to develop and commercialise brodalumab, except in Europe, Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd through an agreement with Amgen.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide. For more information, visit www.leo-pharma.com.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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