VYALEV foscarbidopa and foslevodopa

Drug Class

Dopamine precursor and peripheral decarboxylase inhibitor prodrug combination

Mechanism

Foslevodopa and foscarbidopa are soluble prodrugs of levodopa and carbidopa, converted in vivo to supply levodopa (a dopamine precursor) and carbidopa (a decarboxylase inhibitor) continuously.

Approved Indication

Treatment of advanced Parkinson's disease responsive to levodopa, with severe motor fluctuations.

What This Means For Patients

Vyalev (known as Produodopa internationally) is a 24-hour continuous subcutaneous infusion of levodopa-based prodrugs for advanced Parkinson's disease. Administered via a portable pump, it delivers steady drug levels to reduce motor fluctuations. It is available under the special-import drug policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2024) — source
• EMA — approved (2024) — source

Pivotal Clinical Evidence

• NCT04380142 — Soileau et al., Lancet Neurol 2022 (NCT04380142) — DOI

Sources

• https://news.abbvie.com/2024-10-16-AbbVie-Announces-U-S-FDA-Approval-of-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-with-Advanced-Parkinsons-Disease
• https://www.ema.europa.eu/en/medicines/human/EPAR/produodopa