GSK announces submission to U.S. regulatory authorities for Promacta™ (eltrombopag) for severe aplastic anaemia
Posted: 28 February 2014 | | No comments yet
GlaxoSmithKline plc announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Promacta™…
GlaxoSmithKline plc (LSE:GSK) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Promacta™ (eltrombopag) for the treatment of cytopenias (a reduction in blood cells) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are no approved therapies available for SAA patients unresponsive to IST. Of those patients unresponsive to initial IST, approximately 40% die from infection or bleeding within 5 years of their diagnosis.1
On 3 February 2014, GSK announced that the FDA granted Breakthrough Therapy designation for Promacta in SAA.
The sNDA application is based on the results from an open-label, Phase II National Institute of Health (NIH) study of eltrombopag in 43 heavily pre-treated SAA patients with an insufficient response to IST.
- Valdez JM, et al. Decreased Infection-Related Mortality and Improved Survival in Severe Aplastic Anemia in the Past Two Decades. Clinical Infectious Diseases 2011;52(6):726–735
