Brazil Approves 24‑Hour Subcutaneous Levodopa Therapy for Advanced Parkinson

Overview

• Anvisa granted registration for Vyalev on Monday, May 25, 2026, and the drug will be marketed in Brazil by AbbVie.
• Vyalev combines foslevodopa and foscarbidopa and is delivered as a continuous 24‑hour subcutaneous infusion to keep levodopa levels steadier and reduce motor 'on/off' swings.
• Regulatory approval was based on a roughly 130‑patient, 12‑week phase 3 trial that found a mean increase of 2.72 hours of daily 'on' time without problematic dyskinesia versus 0.97 hour in the control group.
• The most reported adverse effects were infusion‑site reactions, involuntary movements and hallucinations, with the company describing most events as mild or moderate.
• The therapy is positioned as an alternative to deep brain stimulation for patients who are ineligible or refuse surgery, but questions remain about cost, reimbursement, rollout timing and long‑term safety for Brazil’s roughly 220,000 people with Parkinson.