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 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INREBIC (fedratinib hydrochloride) is an oral JAK2-selective tyrosine kinase inhibitor approved in August 2019 for treatment of high-risk primary myelofibrosis and secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia). The drug works by inhibiting JAK2 and FLT3, reducing phosphorylation of STAT3/5 proteins, thereby blocking abnormal cell proliferation and inducing apoptosis in myeloproliferative neoplasms. In preclinical models, fedratinib demonstrated improved survival, reduced splenomegaly, improved blood counts, and reduced fibrosis progression.
$0.1BPart D
13.4 years to LOEMechanism 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)
Worked on INREBIC at Bristol Myers Squibb? Share your interview experience or compensation data (+7 days Pro)
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.