Inrebic (fedratinib)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- fedratinib
- Company
- Bristol Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Myeloproliferative Disorders; Primary Myelofibrosis
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Mon 08 Feb 2021
- Designations
- Orphan
- Application
- EMEA/H/C/005026
- ATC
- L01EJ02
- Official record
- www.ema.europa.eu
Indication
Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.