AbbVie wins FDA nod for advanced Parkinson’s therapy

AbbVie (NYSE:ABBV) has received approval from the U.S. Food and Drug Administration (FDA) for Vyalev (foscarbidopa and foslevodopa) for the treatment adults with advanced Parkinson’s disease.

Vyalev becomes the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson’s disease.

The approval was supported by data from a pivotal Phase 3, 12-week study, in which adults receiving Vyalev treatment reported superior improvement in “on” time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa.

“On” time refers to the periods of time when patients are experiencing optimal motor symptom control, while “off” time is when symptoms return.