Foscarbidopa/foslevodopa
 Chemical structure of foscarbidopa | |
 Chemical structure of foslevodopa | |
| Combination of | |
|---|---|
| Foscarbidopa | Prodrug of carbidopa |
| Foslevodopa | Prodrug of levodopa |
| Clinical data | |
| Trade names | Vyalev |
| Other names | ABBV-951 |
| Pregnancy category |
|
| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
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 is 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,[4] and in Australia in March 2024.[1]
References[edit]
- ^ a b c "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. Retrieved 4 April 2024.
- ^ "Details for: Vyalev". Health Canada. 5 February 2024. Retrieved 3 March 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23]". Health Canada. 23 June 2023. Retrieved 3 January 2024.
- ^ a b "Regulatory Decision Summary for Vyalev". Drug and Health Products Portal. 3 May 2023. Retrieved 4 April 2024.
- ^ Rosebraugh, Matthew; Kym, Philip; Liu, Wei; Facheris, Maurizio; Benesh, Janet (9 April 2019). "A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson's Disease (P3.8-037)". Neurology. 92 (15 Supplement). doi:10.1212/WNL.92.15_supplement.P3.8-037. S2CID 226858541.
- ^ Facheris, Maurizio; Criswell, Susan; Pavasia, Nirav; Pahwa, Rajesh; Locke, Charles; Robieson, Weining; et al. (14 April 2020). "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. 94 (15 Supplement).
- ^ Facheris, Maurizio; Benesh, Janet; Streit, Janet; Robieson, Weining; Zadikoff, Cindy; Standaert, David (14 April 2020). "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. 94 (15 Supplement).
- ^ Rosebraugh, Matthew; Kym, Philip; Liu, Wei; Facheris, Maurizio (14 April 2020). "ABBV-951 Maintains Stable Levodopa Exposure following Subcutaneous Infusion in Parkinson's Disease Patients (543)". Neurology. 94 (15 Supplement). doi:10.1212/WNL.94.15_supplement.543. S2CID 266119262.
- ^ Facheris, Maurizio; Robieson, Weining; Fisseha, Nahome; Standaert, David (13 April 2021). "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. 96 (15 Supplement). doi:10.1212/WNL.96.15_supplement.2251. S2CID 266111372.
- ^ Liu, Angus (22 March 2023). "AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump". Fierce Pharma. Retrieved 4 April 2024.
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