FDA Approves AbbVie's VYALEV for Advanced Parkinson's

The US Food and Drug Administration (FDA) has recently granted approval to AbbVie's new treatment, VYALEV (foscarbidopa and foslevodopa), specifically designed to address motor fluctuations in adults with advanced Parkinson's disease (PD). Parkinson’s disease is a persistent neurological condition characterized by symptoms such as tremors and muscle stiffness, impacting over ten million individuals worldwide.

VYALEV, also referred to as PRODUODOPA, stands out as the first and only subcutaneous, 24-hour infusion therapy based on levodopa to receive approval for this specific use. This treatment is authorized in 35 countries and comes in dosages of 120mg foscarbidopa and 2,400mg foslevodopa per 10ml solution.

Roopal Thakkar, AbbVie's executive vice-president of research and development and chief scientific officer, emphasized the daily struggles faced by those with advanced Parkinson’s disease due to unpredictable motor fluctuations, which worsen as the disease progresses. Thakkar expressed pride in introducing this innovative treatment, highlighting its potential to aid patients through continuous 24-hour administration that effectively manages motor symptoms.

The FDA’s decision was influenced by the findings of the pivotal Phase III M15-736 study. This 12-week clinical trial evaluated the effectiveness of VYALEV’s continuous infusion in patients with advanced Parkinson's disease, comparing it to the traditional oral immediate-release carbidopa/levodopa (CD/LD IR). Additionally, a 52-week open-label study was conducted to assess the long-term efficacy and safety of VYALEV.

In the context of Parkinson’s disease, “on” time refers to periods when patients experience optimal control over their motor symptoms, whereas “off” time denotes the return of symptoms. The primary endpoint of the study was the measurement of “on” time quality, averaged over three consecutive days and normalized to a 16-hour waking period.

The results from the pivotal study indicated that patients receiving VYALEV showed significant improvements in managing motor fluctuations. They experienced increased “on” time and reduced “off” time, without the troublesome dyskinesia that can sometimes accompany treatment. This contrasted with the outcomes for patients who continued with the oral CD/LD IR regimen.

In conclusion, the introduction of VYALEV marks a significant advancement in the treatment of advanced Parkinson’s disease, offering a new option that provides continuous symptom management. The positive results from clinical trials underscore its potential to significantly enhance the quality of life for those affected by this challenging condition.