The US Food and Drug Administration (FDA) has approved AbbVie’s VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson’s disease (PD).
The chronic neurological disorder is marked by symptoms such as tremors and muscle rigidity, and affects more than ten million people globally.
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VYALEV, also known as PRODUODOPA, is the first and only subcutaneous 24-hour infusion of levodopa-based therapy approved for this indication.
The treatment is approved in 35 countries and is available as a 120mg foscarbidopa dose and a 2,400mg foslevodopa per 10ml solution dose.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar stated: “People living with advanced Parkinson’s disease 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.”
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By GlobalDataThe FDA’s approval is based on the results from the pivotal Phase III M15-736 study.
This 12-week trial assessed the efficacy of VYALEV’s continuous infusion in advanced PD patients against oral immediate-release carbidopa/levodopa (CD/LD IR). A 52-week open-label study was also conducted to evaluate the long-term efficacy and safety of the treatment.
In PD, “on” time indicates when patients have optimal motor symptom control, while “off” time refers to the return of symptoms.
The primary endpoint of the study was the quality of “on” time, averaged over three consecutive days and normalised to a waking period of 16 hours.
Results from the pivotal study demonstrated that patients treated with VYALEV experienced significant improvements in motor fluctuations and had an increased “on” time and decreased “off” time without troublesome dyskinesia, compared to those receiving oral CD/LD IR.
In June 2024, the FDA issued a complete response letter for the new drug application of ABBV-951.
