Foscarbidopa/foslevodopa explained

Type:combo
Component1:Foscarbidopa
Class1:Prodrug of carbidopa
Component2:Foslevodopa
Class2:Prodrug of levodopa
Tradename:Vyalev
Pregnancy Au:B3
Routes Of Administration:Subcutaneous
Atc Prefix:None
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2] [3] [4]
Synonyms:ABBV-951

Foscarbidopa/foslevodopa, sold under the brand name Vyalev, is a fixed-dose combination medication used for the treatment of Parkinson's disease. It is a combination of prodrugs for levodopa and carbidopa that was developed by AbbVie.[5] [6] [7] [8] [9]

The combination was refused approval by the US Food and Drug Administration (FDA) in 2023.[10] It was approved for medical use in Canada in May 2023, and in Australia in March 2024.

Notes and References

  1. Web site: Vyalev foslevodopa 2400 mg/10 mL and foscarbidopa 120 mg/10 mL solution for subcutaneous infusion vial (372902) . Therapeutic Goods Administration (TGA) . 28 March 2024 . 4 April 2024.
  2. Web site: Details for: Vyalev . . 5 February 2024 . 3 March 2024.
  3. Web site: Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23] ]. . 23 June 2023 . 3 January 2024.
  4. Web site: Regulatory Decision Summary for Vyalev . Drug and Health Products Portal . 3 May 2023 . 4 April 2024.
  5. Rosebraugh . Matthew . Kym . Philip . Liu . Wei . Facheris . Maurizio . Benesh . Janet . A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson's Disease (P3.8-037) . Neurology . 9 April 2019 . 92 . 15 Supplement . 10.1212/WNL.92.15_supplement.P3.8-037 . 226858541 .
  6. Facheris . Maurizio . Criswell . Susan . Pavasia . Nirav . Pahwa . Rajesh . Locke . Charles . Robieson . Weining . Shprecher . David . Safety and Tolerability During a 4-Week Continuous Subcutaneous Infusion of ABBV-951, a New Drug Formulation for the Treatment of Parkinson's Disease: Final Results of a Phase 1b Study (1384) . Neurology . 14 April 2020 . 94 . 15 Supplement .
  7. Facheris . Maurizio . Benesh . Janet . Streit . Janet . Robieson . Weining . Zadikoff . Cindy . Standaert . David . Safety and Tolerability in Parkinson's Disease Patients Treated with a Continuous Subcutaneous Infusion of ABBV-951: Design of a 52-Week Phase 3 Study (4233) . Neurology . 14 April 2020 . 94 . 15 Supplement .
  8. Rosebraugh . Matthew . Kym . Philip . Liu . Wei . Facheris . Maurizio . ABBV-951 Maintains Stable Levodopa Exposure following Subcutaneous Infusion in Parkinson's Disease Patients (543) . Neurology . 14 April 2020 . 94 . 15 Supplement . 10.1212/WNL.94.15_supplement.543 . 266119262 .
  9. Facheris . Maurizio . Robieson . Weining . Fisseha . Nahome . Standaert . David . Efficacy and Safety of Foslevodopa/Foscarbidopa Versus Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients: Design of a Phase 3, Randomized, Double-Blind, Double-Dummy, Active Controlled 12-Week Trial (2251) . Neurology . 13 April 2021 . 96 . 15 Supplement . 10.1212/WNL.96.15_supplement.2251 . 266111372 .
  10. Web site: Liu . Angus . AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump . Fierce Pharma . 22 March 2023 . 4 April 2024.

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