Vyalev FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 20, 2024.
FDA Approved: Yes (First approved October 16, 2024)
Brand name: Vyalev
Generic name: foscarbidopa and foslevodopa
Dosage form: Injection
Previous Name: ABBV-951
Company: AbbVie Inc.
Treatment for: Parkinson's Disease
Vyalev (foscarbidopa and foslevodopa) is a carbidopa prodrug and levodopa prodrug combination indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
- Vyalev is a levodopa-based therapy administered as a 24-hour subcutaneous infusion, allowing for personalized dosing based on individual needs.
- Parkinson's disease is a progressive and chronic neurological disorder caused by an impaired ability to produce to dopamine due to the degeneration of nerve cells in the substantia nigra part of the brain. Parkinson’s disease is characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance. People with advanced Parkinson’s disease experience complications including motor and non-motor fluctuations and dyskinesia.
- Vyalev is a prodrug combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate) which are converted in vivo to carbidopa and levodopa. Levodopa works by crossing the the blood-brain barrier to the brain where it is then converted to dopamine. Carbidopa works to inhibit the decarboxylation of levodopa.
- FDA approval of Vyalev was supported by results of the Phase 3 M15-736 study that evaluated the efficacy of a continuous subcutaneous infusion of Vyalev compared to oral immediate-release carbidopa/levodopa (CD/LD IR). Findings showed patients receiving Vyalev demonstrated superior improvement in motor fluctuations, with increased "on" time (periods of time when patients are experiencing optimal motor symptom control) without troublesome dyskinesia and decreased "off" time (when symptoms return), compared with oral CD/LD IR.
- Vyalev is administered as a continuous subcutaneous infusion via the Vyafuser™ pump.
- Warnings and precautions associated with Vyalev include falling asleep during activities of daily living, hallucinations/psychosis, impulse control behaviors, and infusion site reactions and infections.
- Common adverse reactions include infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.
Development timeline for Vyalev
Further information
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