AbbVie Inc. (ABBV) Thursday said that the U.S. Food and Drug Administration (FDA) has approved Vyalev for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD).
The approval was supported by the pivotal phase 3 study evaluating Vyalev in adults with advanced PD compared to carbidopa/levodopa, along with another study which assessed the long-term safety and efficacy of Vyalev. Results from the study showed that patients receiving Vyalev demonstrated superior improvement in motor fluctuations, with increased "on" time without troublesome dyskinesia and decreased "off" time, compared with carbidopa/levodopa.
AbbVie said coverage for Medicare patients is expected in the second half of 2025.
Amneal Pharmaceuticals' arbidopa/levodopa combination was approved this year for the treatment of Parkinson's disease, and sold under the brand name Crexont.
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