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HomeLatest Pharma-NewsImago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the...

Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the Treatment of Essential Thrombocythemia

Jan 12, 2020: Imago BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET), a bone marrow disease linked with high platelet counts and potentially catastrophic vascular complications.

Bomedemstat inhibits the enzyme LSD1 (lysine-specific demethylase 1), as a result preventing excess platelet and neutrophil production.

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The FDA grants Fast Track designation in order to facilitate development and expedite the review of therapies with the potential to treat a severe condition where there is an unmet medical need.

A therapeutic that receives Fast Track designation can benefit from the early and frequent communication with agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more speedily.

Bomedemstat is a small molecule that was discovered by Imago BioSciences, inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme essential for the production and normal function of megakaryocytes and for self-renewal of the malignant hematopoietic stem or progenitor cells.

Megakaryocytes are the primary producer of the platelets and cytokines that drive essential thrombocythemia pathogenesis.

http://www.imagobio.com/imago-receives-fast-track-designation-from-u-s-fda-for-bomedemstat-for-treatment-of-essential-thrombocythemia/

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