 | |
| Clinical data | |
|---|---|
| Trade names | Voydeya |
| Other names | ACH-4471 |
| License data | |
| Routes of administration | By mouth |
| Drug class | Complement factor D inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| Chemical and physical data | |
| Formula | C6H3BrFN7O3 |
| Molar mass | 320.038 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
Danicopan, sold under the brand name Voydeya, is a medication used for the treatment of paroxysmal nocturnal hemoglobinuria.[2] It is a complement inhibitor which reversibly binds to factor D to prevent alternative pathway-mediated hemolysis and deposition of complement C3 proteins on red blood cells.[2]
Danicopan was approved for medical use in Japan in January 2024,[3] and in the United States in March 2024.[1][4]
Medical uses
Danicopan is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria.[1][2]
Society and culture
Legal status
In February 2024, the Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Voydeya, intended as add-on therapy to ravulizumab or eculizumab for the treatment of residual hemolytic anemia in adults with paroxysmal nocturnal hemoglobinuria (PNH).[2][5] The applicant for this medicinal product is Alexion Europe.[2]
Names
Danicopan is the international nonproprietary name.[6]
References
- ^ a b c "Voydeya- danicopan tablet, film coated; Voydeya- danicopan kit". DailyMed. 3 April 2024. Archived from the original on 25 April 2024. Retrieved 25 April 2024.
- ^ a b c d e "Voydeya EPAR". European Medicines Agency. 22 February 2024. Archived from the original on 23 February 2024. Retrieved 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Voydeya (danicopan) granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy". AstraZeneca (Press release). 19 January 2024. Archived from the original on 24 February 2024. Retrieved 24 February 2024.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- ^ "First oral treatment against residual hemolytic anemia in patients with paroxysmal nocturnal hemoglobinuria". European Medicines Agency (EMA) (Press release). 23 February 2024. Archived from the original on 24 February 2024. Retrieved 24 February 2024.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
Further reading
- Lee JW, Griffin M, Kim JS, Lee Lee LW, Piatek C, Nishimura JI, et al. (December 2023). "Addition of danicopan to ravulizumab or eculizumab in patients with paroxysmal nocturnal haemoglobinuria and clinically significant extravascular haemolysis (ALPHA): a double-blind, randomised, phase 3 trial". The Lancet. Haematology. 10 (12): e955–e965. doi:10.1016/S2352-3026(23)00315-0. PMID 38030318.
External links
- "Danicopan (Code C148181)". NCI Thesaurus.
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This page was last edited on 25 June 2024, at 06:27