FDA Advisory Committee Meeting Outcome: A Message from Paige Rivard, Levo CEO Sara Cotter

"On Thursday, November 4, 2021, an FDA Advisory Committee meeting was held for LV-101 carbetocin nasal spray. The Advisory Committee placed their vote, and unfortunately, it was 12 (No) and one (Yes) based on the one question - Has the applicant provided substantial evidence of effectiveness for carbetocin nasal spray (LV-101) in the treatment of hyperphagia associated with Prader-Willi syndrome? Did LV-101 show "substantial" effectiveness for hyperphagia? We will keep the community informed as we learn more. We would like to sincerely thank all involved who helped with this historic event. Thank you to the presenters (FDA, Levo Therapeutics, parents, physicians, and all others) who are working so hard to bring treatments to the PWS community. While this was one step back, I know it was a step closer than we've ever been. I look forward to what is to come!"
- Paige Rivard, CEO, PWSA | USA
"We thank our investigators, the patients who enrolled in our trial, and the many PWS community members and advocates who shared their personal thoughts and experiences at today’s meeting, reflecting the significant unmet need for a treatment for PWS. While we are disappointed by the outcome of today’s vote, we appreciated the opportunity to share our data with the Advisory Committee, and we will work with the FDA as it completes its review of our application. We continue to believe that carbetocin can provide a much-needed option for patients based on the favorable benefit/risk profile demonstrated in the clinical development program."
- Sara Cotter, CEO, Levo Therapeutics
About LV-101 (Intranasal Carbetocin)

Carbetocin is an analog of the naturally-occurring neuroendocrine hormone oxytocin.  Carbetocin was designed to have an improved receptor binding profile compared to oxytocin, with greater affinity for the oxytocin receptor and lower affinity for related vasopressin receptors.  Through our licensor, Ferring Pharmaceuticals, carbetocin is approved in over 90 countries outside the United States for the prevention of uterine atony and excessive bleeding during cesarean section delivery, as well as newly approved in the EU following vaginal birth, with an estimated cumulative exposure of over 10 million patients.  LV-101 is an investigational intranasal form of carbetocin, intended to be administered to patients with PWS three times each day before meals.  LV-101 has been granted orphan drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).

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