FDA approves Vyalev for motor fluctuations in advanced Parkinson’s disease
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The FDA has approved Vyalev, a continuous, subcutaneous 24-hour infusion, to address motor fluctuations in adults with advanced Parkinson's disease, according to the manufacturer.
The approval was based on a phase 3 clinical trial evaluating the efficacy of continuous subcutaneous infusion of Vyalev (foscarbidopa/foslevodopa, AbbVie) compared with oral immediate-release carbidopa/levodopa (CD/LD IR) over 12 weeks, followed by a 52-week, open-label extension evaluating long-term safety and efficacy, AbbVie said in a press release.
“This treatment adds another option to our therapeutic arsenal, broadening the spectrum of available therapies,” Okeanis Vaou, MD, FAAN, associate professor in the department of neurology at the University of Texas Health San Antonio, told Healio in an email. “This advancement allows us to make treatment plans more individualized, catering to the unique needs, preferences, and lifestyles of our patients.”
Approximately 130 adults with an advanced disease course were enrolled across 80 sites in the United States and Australia.
The participants were randomly assigned 1:1 to receive either Vyalev plus oral placebo for CD/LD or oral CD/LD IR plus a placebo solution delivered subcutaneously for Vyalev. They were asked to keep a record of their motor states throughout the day in a diary. The researchers averaged the study’s primary endpoint of good “on” time across 3 consecutive days, then adjusted within a typical 16-hour waking period, per the release.
According to data cited in the release, treatment with Vyalev led to improved motor fluctuations as well as greater “on” time without troublesome dyskinesia, and decreased “off” time, compared with oral CD/LD IR.
Adverse reactions associated with treatment were largely non-serious and mild or moderate in severity, with infusion site reactions, hallucinations and dyskinesia the most frequently reported.
“People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses," Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer at AbbVie, stated in the release. “"We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev.”
Editor's Note: This story was updated on Nov. 7, 2024 to add original comment.