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FDA has no appetite for Levo's metabolic disorder drug and asks for new trial

The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said the data submitted were insufficient to support approval and the regulator wants the company to run another clinical trial.
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FDA rejects new drug application for internasal carbetocin to treat Prader-Willi syndrome

The FDA’s Division of Psychiatry has rejected a new drug application for treating hyperphagia, anxiousness and distress associated with Prader-Willi syndrome, according to a press release.As Healio previously reported, the FDA granted priority review for LV-101 (intranasal carbetocin, Levo Therapeutics) in July 2021. In a complete response letter, the FDA determined the therapy was safe and
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Source: healio.com

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