Review of Intranasal LV-101 Therapy Gets FDA Priority Status

Review of Intranasal LV-101 Therapy Gets FDA Priority Status

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Review of Intranasal LV-101 Therapy Gets FDA Priority Status

The U.S. Food and Drug Administration (FDA) has granted priority review to LV-101 (intranasal carbetocin), an investigational treatment for the distress behaviors and insatiable hunger that accompany Prader-Willi syndrome (PWS). The decision reduces the review period for the medication’s new drug application (NDA) to six months, down from the standard 10 months. Therapy developer Levo Therapeutics expects a decision on approval from the FDA by the end of the year. “We are genuinely appreciative that…

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