NDAORALTABLETPriority Review
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
4/8 — 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 . First approved in 2023.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo 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, disrupting oncogenic pathways in MYCN-amplified neuroblastoma. The drug restores the LIN28/Let-7 metabolic balance and induces senescence in cancer cells, demonstrating cytostatic activity. It is approved for pediatric neuroblastoma patients with MYCN amplification.
Growth9.3 years to LOE
Early-stage growth product with no current direct competitors; commercial team scaling to establish market presence in a niche pediatric oncology segment.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
IWILFIN offers career opportunity in a rare pediatric oncology space with minimal competition and strong patent exclusivity. Early commercial-stage growth positions team members to build market presence from launch baseline in a niche, high-value indication.
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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.