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FDA Approves Frontline Eltrombopag for Severe Aplastic Anemia

Gina Columbus @ginacolumbusonc
Published: Friday, Nov 16, 2018

The FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia (SAA), according to Novartis, the manufacturer of eltrombopag.1 The agency also granted the agent a breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome (H-ARS).

Regarding the breakthrough therapy designation, research and development of eltrombopag for H-ARS is being conducted under contract with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority as potential use following radio/nuclear threats, specifically to treat patients exposed to myelosuppressive doses of radiation. Eltrombopag has been shown to decrease the risk of hemorrhage in patients with H-ARS, Novartis stated.


  1. FDA Approves Novartis Drug Promacta for First-Line SAA and Grants Breakthrough Therapy Designation for Additional New Indication. Novartis. Published November 16, 2018. Accessed November 16, 2018.
  2. Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag added to standard immunosuppression for aplastic anemia. N Engl J Med. 2017;376(16):1540-1550. doi: 10.1056/NEJMoa1613878.

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