FDA Approves AbbVie’s Parkinson’s Therapy Vyalev

AbbVie has announced that its Parkinson’s disease (PD) therapy has received approval from the US Food and Drug Administration (FDA) for addressing motor fluctuations in adults who are in the advanced stages of this chronic movement disorder.

The newly approved therapy, Vyalev, is a solution containing foscarbidopa and foslevodopa, which are prodrugs of the established medications carbidopa and levodopa (CD/LD). Vyalev is administered as a 24-hour continuous subcutaneous infusion, providing a steady supply of the medication throughout the day and night.

Parkinson’s disease is a progressive neurological condition that affects over ten million people globally. The disease is marked by symptoms such as tremors, muscular rigidity, slowed movement, and balance difficulties. Patients with PD often experience a fluctuation between an ‘on’ state, where symptoms are well managed, and an ‘off’ state, where symptoms resurface. This fluctuation becomes particularly challenging in advanced stages of the disease, where patients may also suffer from involuntary movements called dyskinesia. These movements can severely disrupt daily activities and overall quality of life.

The FDA’s approval of Vyalev was influenced by the positive outcomes from the late-stage M15-736 clinical trial. This study involved approximately 130 patients with advanced PD, who were randomly assigned to receive either Vyalev or oral immediate-release CD/LD over a 12-week period. The patients treated with Vyalev showed more significant improvements in managing motor fluctuations. Specifically, they experienced increased ‘on’ time without the troublesome dyskinesia and reduced ‘off’ time compared to those taking oral CD/LD.

Additionally, the approval was bolstered by data from a 52-week open-label study of Vyalev, which further confirmed its efficacy and safety for long-term use.

Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, expressed pride in the advancement, emphasizing the daily challenges faced by individuals with advanced PD due to unpredictable motor fluctuations. Thakkar highlighted that Vyalev offers a new solution for those needing continuous motor symptom management through its 24-hour administration.

This approval follows closely on the heels of AbbVie’s recent announcement of positive top-line results from a phase 3 study of another investigational PD drug, tavapadon, aimed at adults in the early stages of the disorder. The drug, a D1/D5 dopamine receptor partial agonist, showed a statistically significant improvement from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale parts two and three combined score at week 26 when compared to placebo. This result met the primary endpoint of the study.

AbbVie has stated that it will present the full results from the TEMPO-1 trial at upcoming medical conferences and use the data to support regulatory submissions for tavapadon.

Overall, the approval of Vyalev marks a significant step forward in the treatment of advanced Parkinson’s disease, providing patients with a new option to better manage their motor symptoms continuously throughout the day.