AbbVie's Parkinson's drug approved, finally
AbbVie’s Vyalev, a 24-hour continuous subcutaneous infusion for advanced Parkinson’s disease, finally gained FDA approval in 2024, but its journey was not without setbacks. Initially submitted in late 2023, the application faced delays as the FDA requested more data to support its efficacy claims. Vyalev’s phase 3 trials demonstrated improved motor control, reducing stiffness and tremors compared to oral medications, which lose their effectiveness over time.
This non-surgical therapy provides consistent symptom management, a critical advancement for patients with severe motor fluctuations. AbbVie now aims to ensure its accessibility, with Medicare coverage anticipated in 2025.
While regulatory delays are not uncommon, Vyalev’s approval marks a step forward in addressing long-standing challenges in Parkinson’s treatment. The question now is how quickly the therapy will reach those in need and what its long-term impact will be in real-world settings.
AbbVie’s next steps include working closely with insurance providers to ensure patient access, with a particular focus on Medicare coverage expected in 2025.
As more therapies like Vyalev come to market, the industry continues to move toward personalized, non-surgical solutions that aim to improve the quality of life for those with chronic, progressive diseases like Parkinson’s. — Andrea Corona
