FDA announces approval of Omegaven
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, the U.SFDAto approve Omegaven as a calorie and fatty acid supplement for children suffering from "intestinal nutrition-related bile siltation."OmegavenOmegaven isby Fresenius Kabi(developed, Omegaven is made up of fish oil and its main content is omega-3 fatty acidsin animal experiments, researchers found that intravenous fish oil could relieve bile siltationAs a result, the therapy is expected to achieve the same effect in the human body, providing nutrition while reversing the patient's conditionthe therapeutic potential of this treatment was validated in two publicly labeled, single-center clinicaltrialsThe two trials recruited children aged 2 and 5 and treated them with OmegavenThe control group had historical data and had been treated with a fat emulsion based on soy oilstudies have shown that Omegaven has similar effects to standard therapies in terms of children's weight gainAt the direct bilirubin (DBil) level, the level of the child dropped from 2.0 mg/dL at the time of the start of treatment to 0.60 mg/dL (median)Thenew drug (previously qualified as a priority review by the FDA and an orphan drug) 's approval today is a further sign of the FDA's recognition of the safety and efficacy of the new drug
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