Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats extravascular hemolysis (EVH). Sold as Voydeya. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Danicopan (sold as Voydeya), first approved Mar 29, 2024, with 0 new uses approved and 0 published complete response letters.
First approved: Mar 29, 2024
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.8M
Orphan exclusivity until: Mar 29, 2031
First approved in the EU: Apr 19, 2024
First approved in Japan: Jan 18, 2024
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 2 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Voydeya, new ingredientA drug with a new active ingredient indicated for the treatment of paroxysmal nocturnal haemoglobinuria. · Alexion Pharma GK · Jan 18, 2024 · Review report
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Voydeya REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Jun 27, 2025
Clinical Trials
5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
