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FDA Medication Tracker

← All approvals · Heart & blood · 2024

Voydeya (danicopan)

The FDA approved Voydeya (danicopan) on March 29, 2024 to treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria.
Brand name
Voydeya
Generic name
danicopan
FDA approval date
March 29, 2024
Approved use (FDA wording)
To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria
Company
Alexion Pharms Inc.
Application
NDA218037
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Complement Factor D Inhibitor [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Heart & blood

Indications and usage, from the FDA label

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). VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ). 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. 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.

Official sources

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