¡New FDA approval for the treatment of Parkinson’s disease!
Improvement in periods of optimal symptom control
October 29 2024
La enfermedad de Parkinson (PD) is a progressive, age-related neurodegenerative disorder characterized by tremor, muscle rigidity, slowness of movement, and difficulty maintaining balance. PD affects millions of people worldwide. Basically, it is characterized by selective degeneration of the dopaminergic neurons of the nigrostriatal pathway and the intraneuronal aggregation of α-synuclein (a physiological neuronal protein abundantly expressed in the brain), but which in the case of PD is misfolded and generates the formation of Lewy bodies and neurites.
In the past, the aggregated protein inclusions called Lewy bodies found in rare forms of familial PD and in cortical dementia with Lewy bodies (LBD) have been found to be predominantly alpha-synuclein.
Just days ago, the FDA approved Vyalev (foscarbidopa and foslevodopa), the first 24-hour subcutaneous levodopa infusion for adults with advanced Parkinson’s, offering a nonsurgical alternative for continuous control of motor symptoms. This treatment responds to the need for effective options as oral medications lose effectiveness in advanced stages.
The approval is based on a 12-week Phase 3 study that showed how Vyalev reduces motor fluctuations versus standard oral therapy, increasing “on time” (optimal symptom control) and reducing “off time” (return of motor symptoms).
An additional 52-week study supported its long-term safety and efficacy, with mild adverse effects such as infusion site reactions and hallucinations. Abbvie highlights this innovation as a step forward in improving the quality of life of patients facing daily motor fluctuations due to the progression of Parkinson’s. Medicare in the United States is expected to cover the treatment in the second half of 2025, depending on the insurance plan.