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news.Alimentary Health has announced that the Office of Orphan Products Development of the FDA, has granted orphan drug designation to bifidobacterium infantis 35624 for the treatment of pediatric ulcerative colitis.
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This new orphan drug designation builds on the previously granted designation to Alimentary Health for pediatric Crohn’s disease. The pediatric population is defined as patients who are aged sixteen or less.
Barry Kiely, CEO of Alimentary Health, said: “The achievement of orphan drug designation for one of our probiotic technologies is an important step towards having probiotics serve as drug treatment for certain gastrointestinal and inflammatory conditions. This is and will continue to be a key goal of our research efforts.”