FDA Approves AbbVie's 24-Hour Infusion for Advanced Parkinson's

The U.S. Food and Drug Administration (FDA) has officially approved AbbVie’s Vyalev, a medication identified by its components foscarbidopa and foslevodopa. This innovative treatment stands out as the first subcutaneous 24-hour continuous infusion therapy designed for managing motor fluctuations in adults who have advanced Parkinson’s disease.

Vyalev is a non-surgical option that aims to offer more stable control of motor symptoms compared to traditional oral medications. Over time, oral treatments can lose their effectiveness as Parkinson’s disease advances, making the introduction of Vyalev particularly significant.

The FDA's approval of Vyalev is based on robust evidence from a phase 3 clinical trial. This study demonstrated that Vyalev significantly increased “on” time—periods when the medication is effectively managing symptoms—without causing troublesome dyskinesia, which are involuntary movements that can be a side effect of Parkinson's treatments. Patients on Vyalev experienced improved control over motor symptoms, resulting in reduced instances of stiffness and tremors throughout the day.

One of the notable features of Vyalev is its personalized dosing system, which allows for continuous medication delivery throughout the day and night. This tailored approach ensures that patients receive a consistent therapeutic effect, potentially improving their overall quality of life.

AbbVie has announced plans to make Vyalev accessible to patients according to their individual insurance coverage. The company anticipates that Medicare will start covering this treatment in the latter half of 2025, further expanding access to those in need.