Eltrombopag to treat aplastic anaemiaJanuary 14, 2019
USFDA has expanded the label for eltrombopag (Promacta) for first-line treatment of severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy (IST).
Eltrombopag is an oral thrombopoietin receptor agonist (TPO-RA) that is already approved for SAA for patients who have had an insufficient response to IST. It is also approved for adults and children with chronic immune thrombocytopenia (ITP) who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.
The FDA’s approval is based on a study showing that 44% of definitive IST-naive SAA patients achieved a complete response at 6 months when treated with eltrombopag concurrently with standard IST, which was 27% higher than the complete response rate historically observed with the standard.