AbbVie gains FDA approval for latest treatment for Parkinson's Disease

AbbVie, the speciality biopharmaceutical company has once again made headway in the treatment of Parkinson’s disease. 

The treatment, named VYALEV™, is a combination of foscarbidopa and foslevodopa, the approval of which comes after the completion of a Phase III clinical trial. The trial took place in the form of a 12-week randomised, double-blind, double-dummy, active-controlled study to evaluate the efficacy, safety and tolerability of the continuous subcutaneous infusion in adult patients with advanced Parkinson's disease. 

“For too long, the Parkinson's community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required," commented Robert A. Hauser, Professor of Neurology and Director of the Parkinson's and Movement Disorder Centre at the University of South Florida. "This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."

The drug from AbbVie was compared to an oral immediate-release carbidopa/levodopa (CD/LD IR)1. The comparison was also made over a 52-week open label study to evaluate the long-term safety and to ensure that the findings were valid and the treatment was suitable for approval for long-term treatment and ultimately help patients living with Parkinson's disease. 

The study showed that showed that there was significant improvement in motor fluctuations in patients that received VYALEV™, with the main outcomes showing that the time that patients experienced troublesome dyskinesia was decreased and the time without experiencing this was increased compared to the oral dosage form that was acting as a control. this off time without periods of dyskinesia is in reference to the periods of time where the patients can function with normal or optimal motor control. 

"People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses," explained Roopal Thakkar, Executive Vice President, Research & Development, and 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."

The study showed that there were some adverse reactions with the use of VYALEV™, but they were mild and moderate in severity. The most frequent adverse reactions were events at the infusion sites, hallucinations, and further dyskinesia. 

VYALEV™ has already been approved in 35 countries and used in more than 4200 patients across the world. AbbVie is continually working with regulatory bodies to bring the treatment to as many people with Parkinson's disease as possible. So this latest approval marks a huge milestone in increasing the access to this treatment for this group of people.

Source:

AbbVie. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. [Date Accessed 21.10.2024] https://news.abbvie.com/2024-10-17-U-S-FDA-Approves-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-Living-with-Advanced-Parkinsons-Disease