AbbVie Reports the US FDA’s Approval of Vyalev (Foscarbidopa and Foslevodopa) for Treating Advanced Parkinson's Disease
Shots:
- The US FDA has granted approval to Vyalev (SC), 24-hour levodopa infusion for treating motor fluctuations in advanced Parkinson's disease. Access depends on individual insurance, with Medicare coverage planned during H2’25
- Approval was based on the P-III (M15-736) trial assessing the safety & efficacy of Vyalev (SC) vs oral immediate-release carbidopa/levodopa (CD/LD IR) for 12wks. among adults (n=130) with PD and an OLE trial for investigating its long-term effectiveness for another 52wks.
- Trial depicted improvement in motor fluctuations, with increased "on" time and reduced "off" time. Most AEs were mild to moderate, with the most frequent being infusion site events, hallucinations & dyskinesia
Ref: AbbVie | Image: AbbVie
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
