NDAORALTABLETPriority Review
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
IWILFIN (eflornithine hydrochloride) by AbbVie is (odc), the first and rate-limiting enzyme in the biosynthesis of polyamines and a transcriptional target of mycn . Approved for hirsutism. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IWILFIN (eflornithine hydrochloride) is an oral small-molecule inhibitor of ornithine decarboxylase (ODC) that suppresses polyamine biosynthesis, particularly effective in MYCN-amplified neuroblastoma. The drug restores balance in the LIN28/Let-7 metabolic pathway and induces senescence in cancer stem cells. It is approved for hirsutism but demonstrates cytostatic activity in preclinical neuroblastoma models.
LOE Approaching9.8 years to LOE
Product approaching loss of exclusivity in ~0.6 years with moderate competitive pressure (35%), likely triggering cost-reduction and portfolio repositioning initiatives.
Mechanism of Action
(ODC), the first and rate-limiting enzyme in the biosynthesis of polyamines and a transcriptional target of MYCN . Polyamines are involved in differentiation and proliferation of mammalian cells and are important for neoplastic transformation. Inhibition of polyamine synthesis by eflornithine…
Indications (1)
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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.