AbbVie’s Parkinson’s disease (PD) therapy has been approved by the US Food and Drug Administration (FDA) to treat motor fluctuations in adults with advanced stages of the chronic movement disorder.
Vyalev is a solution of foscarbidopa and foslevodopa, the prodrugs for standard-of-care medicines carbidopa and levodopa (CD/LD), and is delivered as a 24-hour continuous subcutaneous infusion.
More than ten million people worldwide are living with PD, a progressive neurological disorder characterised by symptoms such as tremor, muscle rigidity, slowness of movement and difficulty with balance.
Patients report switching from an ‘on’ state, when their symptoms are generally well controlled, to an ‘off’ state, when their symptoms return. Those with advanced stages of the disease may also experience involuntary movements, known as dyskinesia, which can significantly impact daily activities.
The FDA’s decision was based on positive results from the late-stage M15-736 study, which randomised approximately 130 advanced PD patients to receive Vyalev or oral immediate-release CD/LD for 12 weeks.
Vyalev-treated patients demonstrated superior improvement in motor fluctuations, with increased ‘on’ time without troublesome dyskinesia and decreased ‘off’ time, compared with oral CD/LD.
Data from a 52-week open-label study of Vyalev also supported the approval.
Roopal Thakkar, executive vice president, research and development, and chief scientific officer at AbbVie, said: “People living with advanced PD experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses.
“We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev.”
The approval comes less than a month after AbbVie shared positive top-line results from a phase 3 study of its investigational PD drug tavapadon in adults with early stages of the disorder.
Patients treated with the D1/D5 dopamine receptor partial agonist experienced 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 compared to placebo, meeting the study’s primary endpoint.
The company said that full results from the TEMPO-1 trial will be submitted for presentation at future medical meetings and used to support regulatory submissions of the candidate.