torsdag, 1 oktober 2015
The New England Journal of Medicine (NEJM) has published positive results from two pivotal, multi-centre, Phase III studies – AMAGINE-2 and AMAGINE-3 - demonstrating that treatment with brodalumab resulted in significant clinical improvements in patients with moderate to severe psoriasis and was superior to both placebo and ustekinumab, a leading approved treatment for psoriasis.
Detailed results and safety information as published in NEJM can be viewed here.
Bing Yao, Senior Vice President, Research and Development and Head of the Respiratory, Inflammation & Autoimmunity Innovative Medicines unit at MedImmune, AstraZeneca’s global biologics research and development arm, said: “Publication of these data in NEJM underscores the importance of brodalumab as a potential new treatment for people with psoriasis, a serious, chronic disease that can have an overwhelming, negative impact on patients’ lives. We look forward to progressing this novel molecule to regulatory submissions in the near future.”
Brodalumab, a fully human monoclonal antibody, is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F, A/F and C) to the receptor. Previous results reported from the two studies can be viewed here: AMAGINE-2 and AMAGINE-3.
The studies were funded by AstraZeneca and Amgen, the former sponsor of the brodalumab programme. AstraZeneca recently announced it has entered into a collaboration with Valeant Pharmaceuticals, granting Valeant an exclusive license to develop and commercialise brodalumab. Regulatory submissions in the United States and European Union for brodalumab in moderate to severe psoriasis are planned for the fourth quarter of 2015.
NOTES TO EDITORS
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location. Approximately 125 million people worldwide have psoriasis, and 80 percent of those patients have plaque psoriasis.
Brodalumab is a novel, fully human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands 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.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. 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
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