Fedratinib: First Approval

Fedratinib (INREBIC ® ) is a JAK2-selective inhibitor that has been developed as an oral treatment for myelofibrosis. In August 2019, fedratinib received its first global approval in the USA for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia...

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Bibliographic Details
Published in:Drugs (New York, N.Y.) N.Y.), 2019-10, Vol.79 (15), p.1719-1725
Main Author: Blair, Hannah A.
Format: Article
Language:English
Subjects:
AdisInsight Report
Adult
Bone marrow
Cell growth
Clinical Trials, Phase III as Topic
Drug dosages
Glycoproteins
Humans
Internal Medicine
Janus kinase 2
Janus Kinase 2 - analysis
Janus Kinase 2 - metabolism
Kinases
Leukemia
Medicine
Medicine & Public Health
Mutation
Myelofibrosis
Oral administration
Pharmacokinetics
Pharmacology/Toxicology
Pharmacotherapy
Phosphorylation
Polycythemia
Polycythemia vera
Primary Myelofibrosis - drug therapy
Primary Myelofibrosis - metabolism
Protein Kinase Inhibitors - chemistry
Protein Kinase Inhibitors - pharmacology
Pyrrolidines - chemistry
Pyrrolidines - pharmacology
Sulfonamides - chemistry
Sulfonamides - pharmacology
Tumors
Vitamin B
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Description
Summary:Fedratinib (INREBIC ® ) is a JAK2-selective inhibitor that has been developed as an oral treatment for myelofibrosis. In August 2019, fedratinib received its first global approval in the USA for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Phase III clinical development for myelofibrosis is ongoing worldwide. This article summarizes the milestones in the development of fedratinib leading to this first approval for myelofibrosis.
ISSN:0012-6667
1179-1950
DOI:10.1007/s40265-019-01205-x