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Market
Main Regulatory Challenge for LUMRYZ in 2025?
2
Resolution / Starting Odds
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Story
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.
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