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American pharmaceutical company Abbvie has secured approval from the US Food and Drug Administration for its innovative Parkinson’s disease (PD) therapy, Vyalev.

Vyalev, whose active ingredients consists of a combination of foscarbidopa and foslevodopa, is a unique therapy administered subcutaneously as a 24-hour continuous infusion in the management of motor fluctuations in adult patients with advanced PD.

Foscarbidopa and foslevodopa are prodrugs of carbidopa and levodopa, respectively.

"People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses," empathized Roopal Thakkar, M.D., chief scientific officer, AbbVie.

"We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."

 

Roopal Thakkar

Administration is through a specialized dosing system where a pump continuously administers the medication.

This delivery method offers a significant convenience advantage over oral medication, avoiding drawbacks such as a short half-life, which makes it challenging to manage symptoms over time.

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This convenience will serve as a reprieve for more than 10 million people globally who suffer from Parkinson’s disease, a condition that has debilitating symptoms including tremor, muscle rigidity, slowness of movement, and difficulty with balance.

Abbvie will breathe a huge sigh of relief after prior applications for the drug were outrightly rejected by the FDA, with the regulator sighting issues with a third-party manufacturer listed in Abbvie’s application as well as information gaps on the subcutaneous pump device.

This recent approval is backed by data from a Phase III study where adult patients with advanced PD administered with Vyalev showed better improvement in motor fluctuations in comparison to those who received oral immediate-release carbidopa/levodopa.

During the study, Vyalev patients had a superior increase in “on” time (when symptoms are well managed) and decreased “off” time (characterized by tremor, stiffness, and difficulty moving).

An estimated 130 patients across 80 sites in the US and Australia participated in the trial.

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