AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for this specific indication.
Vyalev represents a significant advancement in the treatment of advanced PD. It is a solution of carbidopa and levodopa prodrugs designed for 24-hour continuous subcutaneous infusion. A pivotal Phase III study demonstrated that patients treated with Vyalev experienced superior improvement in motor fluctuations, with an increase in “on” time without troublesome dyskinesia and a reduction in “off” time, as compared to those taking oral carbidopa/levodopa (CD/LD IR).
This FDA approval is a milestone for AbbVie and offers a new treatment option for patients with advanced PD, addressing a critical unmet need in the management of motor fluctuations associated with the disease.- Flcube.com
