FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year

On Thursday, the FDA approved AbbVie Inc’s (NYSE:ABBV) Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations in adults with advanced Parkinson’s disease (PD).

The approval was supported by the pivotal 12-week Phase 3 study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev.

Also Read: AbbVie Says Pivotal Trial For Parkinson’s Candidate Meets Its Primary Goal In Patients With Early Disease.

Findings from the pivotal study showed patients receiving Vyalev demonstrated a superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with oral CD/LD IR.

“On” ...