Tagraxofusp – API Insight, 2018

Tagraxofusp, sold under the brand name of Elzonris, is an Interleukin 3 (IL-3) conjugated truncated diphtheria toxin. It is composed of catalytic and translocation domains of diphtheria toxin fused via Met-His linker to a full-length human IL-3.

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Tagraxofusp was developed by Stemline Therapeutics Inc. and was approved in December 2018, as the first therapy for blastic plasmacytoid dendritic cell neoplasm. This drug achieved approval after being designed with the title of breakthrough therapy, priority review, and orphan drug status.

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Tagraxofusp is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients over 2 years old.

This treatment allows an alternative for the previous intense treatment which consisted of intensive chemotherapy followed by bone marrow transplantation. Some of the side-effects include fatigue, peripheral edema and weight increase.

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This report provides details of the drug and the API manufacturers across the 7 major markets which includes U.S, EU5, and Japan. It includes the overview, mechanism, regulatory milestones, strategic developments, the historical and forecasted sales.

The pipeline analysis of the drug by phase which would include the product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology and others.

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