Sandoz's Zessly receives approval from European Commission.
M2 PHARMA-May 28, 2018-Sandoz's Zessly receives approval from European Commission
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It was reported on Friday that the European Commission has approved Germany-based Sandoz's Zessly (infliximab) for the treatment of gastroenterological, rheumatological and dermatological diseases.
The product has been approved for use for rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. It works by blocking the action of tumour necrosis factor-alpha in patients with certain autoimmune diseases in which excess TNF-alpha activity may be harmful or cause onset of disease. By blocking the action of TNF-alpha, infliximab inhibits an underlying cause of inflammation.
The European Commission approval was based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed the product's safety, efficacy and quality.
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|Date:||May 28, 2018|
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