Posted by Michael Wonder on 19 Jan 2022
Levo Therapeutics receives complete response letter from FDA for its new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
18 January 2022 - Levo Therapeutics announced today that it has received a complete response letter from the U.S. FDA regarding its new drug application for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and distress associated with Prader-Will syndrome.
The FDA's Division of Psychiatry concluded that, while LV-101 appears to be generally safe and well-tolerated, the efficacy data available for the proposed 3.2 mg dose of LV-101 were insufficient for approval.
