In a 93-patient Phase 3 clinical trial, Glaxo's (GSK) Promacta/Revolade (eltrombopag) achieves its primary endpoint of a statistically significant improvement in platelet counts in pediatric patients with chronic idiopathic thrombocytopenic purpura (cITP). 39.7% of patients attained a consistent platelet count for 6 - 8 weeks compared to 3.4% in the control group. The safety profile was also consistent for the established profile for eltrombopag.
The potential use of the product in the pediatric setting is a label expansion. Glaxo has not disclosed a timeline for its regulatory submissions.