Levo Therapeutics announced that the FDA has accepted the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with a decision about approval expected by the end of 2021. LV-101 for PWS was granted Fast Track designation by the FDA in 2019.
In August 2020, Levo said that a Phase 3 trial of LV-101 that had stopped enrolling PWS patients early as a result of the COVID-19 pandemic had missed its primary endpoint but demonstrated benefit in several secondary endpoints. In 2017, Levo licensed the intranasal carbetocin from Ferring Pharmaceuticals, which had completed Phase 2 development of the nasal spray for PWS in 2014. and In June 2018, Levo announced that it would restart the clinical development program by the end of that year, and it initiated the Phase 3 trial in December 2018.
Levo Therapeutics CEO Sara Cotter commented, “We are genuinely appreciative that FDA has accepted our NDA for Priority Review. We are looking forward to working with the agency during the coming months. If approved, intranasal carbetocin will be the first specific treatment for the significant and disabling behavioral symptoms of PWS.”
The Foundation for Prader-Willi Research’s Director of Research Programs, Theresa Strong, said, “This application is a substantial milestone for the PWS community, building on extensive scientific investigation of the neurobiological underpinnings of the syndrome. We look forward to continuing to help the PWS community share its perspective on the challenges that our loved ones face, our treatment preferences, and how LV-101 presents an opportunity to address these needs.”
Read the Levo Therapeutics press release.
