AbbVie Secures FDA Approval for Vyalev, a New Continuous Parkinson's Disease Therapy

AbbVie made a breakthrough in 2015 with its Parkinson’s disease treatment Duopa, an infusion pump therapy that helped drive innovation in drug delivery systems. By bypassing the limitations of oral treatments, Duopa set the stage for more advanced therapies. Now, after facing multiple delays, AbbVie has secured FDA approval for Vyalev, a more convenient subcutaneous therapy for Parkinson’s patients.

Vyalev, formerly known as ABBV-951, contains prodrugs foscarbidopa and foslevodopa, which are converted into the active medicines carbidopa and levodopa after entering the body. Administered via a 24-hour continuous infusion, Vyalev is designed to manage motor fluctuations in adults with advanced Parkinson’s disease.

Building on the success of Duopa—which required a stomach tube for drug delivery—Vyalev offers a significant improvement in convenience by using a pump that continuously delivers the medication under the skin. This avoids the challenges of oral therapies, which have a short half-life and often lead to inconsistent symptom control.

AbbVie’s chief scientific officer, Dr. Roopal Thakkar, highlighted the importance of the innovation, noting that Vyalev addresses the daily challenges of motor fluctuation management for patients with advanced Parkinson’s. The therapy aims to provide better motor symptom control through its continuous 24-hour administration.

The FDA approval follows two prior rejections, with the first related to concerns about the subcutaneous pump device, and the second involving issues at a third-party manufacturer. Despite these setbacks, analysts at Evercore ISI predict Vyalev could become one of AbbVie’s major launches, potentially generating over $2 billion in peak sales.

Vyalev showed promising results in a phase 3 study, where it significantly increased patients' "on" time—periods without dyskinesia—compared to oral levodopa/carbidopa. On average, Vyalev increased “on” time by 2.72 hours versus 0.9 hours for the control group during a 16-hour wake period.

AbbVie’s approval puts it ahead of Mitsubishi Tanabe Pharma Corporation, whose own continuous subcutaneous levodopa/carbidopa therapy was delayed by an FDA rejection. Supernus Pharmaceuticals also faced its third rejection for an apomorphine infusion pump designed to treat “off” episodes in Parkinson’s patients.