NDAORALTABLETPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IDHIFA (enasidenib mesylate) is an oral small-molecule inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) approved for relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation. It represents a targeted approach to treating a genetically-defined subset of AML patients by blocking the production of 2-hydroxyglutarate, an oncometabolite that drives leukemic transformation.
$119MPart D
Peak8.2 years to LOEStrong commercial performance at peak lifecycle with modest Medicare penetration indicates stable commercial team supporting a specialty oncology franchise with sustainable revenue.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
$119M Medicare spend — this is a commercially significant brand
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.