AbbVie has received FDA approval for its new combination therapy, Vyalev, which aims to provide longer-lasting control over motor symptoms in patients with advanced Parkinson's disease.
Vyalev is unique in that it utilizes "prodrug" formulations of carbidopa and levodopa, which are activated only after being metabolized in the body. This approach is particularly beneficial for patients who struggle with traditional oral medications.
Vyalev is the first levodopa-based therapy to be administered as a continuous 24-hour infusion, offering a new option for patients who have difficulty swallowing pills.
AbbVie anticipates that patient access to Vyalev will vary based on individual insurance plans, with Medicare coverage expected to roll out in the latter half of 2025.
The company projects that peak annual sales for Vyalev could exceed $1 billion.
This approval follows AbbVie's success with tavapadon, a drug acquired through its purchase of Cerevel Therapeutics, which demonstrated promising results in managing motor fluctuations and extending symptom control.
The introduction of Vyalev could reshape the treatment protocols for advanced Parkinson's disease and offer hope to patients who have exhausted other options.