NDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
Priority Review
INREBIC (fedratinib hydrochloride) by Bristol Myers Squibb is 2 (jak2) and fms-like tyrosine kinase 3 (flt3). Approved for high-risk primary, secondary (post-polycythemia vera, post-essential thrombocythemia) myelofibrosis (mf) (). First approved in 2019.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INREBIC (fedratinib hydrochloride) is an oral JAK2-selective inhibitor approved for high-risk primary and secondary myelofibrosis. It works by inhibiting abnormal JAK2 activation, reducing STAT3/5 phosphorylation, and inducing apoptosis in myeloproliferative neoplasm cells. In clinical models, fedratinib improved survival, blood counts, splenomegaly, and fibrosis.
$50MPart D
Peak13.1 years to LOEThe product is at peak commercial maturity with ~2,400 Part D claims in 2023; manufacturing and clinical development teams are likely stable to optimizing operations.
Mechanism of Action
2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor with higher inhibitory activity for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms (MPNs), including myelofibrosis and polycythemia…
Indications (3)
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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.