FDA announcements and Avadel Pharmaceuticals press releases

FDA Approves AbbVie’s Vyalev for Parkinson’s on 3rd Attempt, Avadel’s LUMRYZ (CIII) for Narcolepsy

Oct 17, 2024, 02:15 PM

The U.S. Food and Drug Administration (FDA) has approved AbbVie's Vyalev™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion for adults with advanced Parkinson's disease. This approval marks a significant milestone for AbbVie, following previous rejections, and is the third attempt for the company. Additionally, the FDA has approved Avadel Pharmaceuticals' LUMRYZ™ (sodium oxybate) extended-release oral suspension (CIII) for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy. This approval broadens the use of LUMRYZ and intensifies competition with treatments from Jazz Pharmaceuticals.