Voydeya FDA Approval History
Last updated by Judith Stewart, BPharm on April 2, 2024.
FDA Approved: Yes (First approved March 29, 2024)
Brand name: Voydeya
Generic name: danicopan
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Paroxysmal Nocturnal Hemoglobinuria
Voydeya (danicopan) is a complement factor D inhibitor used for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria.
- Voydeya is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
Limitations of Use: Voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. - PNH is a rare, chronic, progressive and potentially life-threatening blood disorder characterized by hemolytic anemia and thrombosis. It is caused by a mutation in the PIGA gene in hematopoietic stem cells that results in the production of blood cells that are missing important protective surface proteins. The missing proteins enable the body's complement system to 'attack' and destroy or activate the abnormal blood cells.
- Voydeya is a first-in-class oral Factor D inhibitor that works by selectively inhibiting Factor D, a complement system protein that plays a key role in the amplification of the complement system response.
- FDA approval of Voydeya was based on positive results from the pivotal ALPHA Phase III trial.
- Voydeya tablets are administered three times a day orally, with or without food.
- Warnings and precautions associated with Voydeya include increases hepatic enzymes and hyperlipidemia.
- The most common adverse reaction is headache.
Development timeline for Voydeya
Further information
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