Promacta Approval Expanded for Children With Chronic ITP
Builds on recent approval for ages 6 years and up for chronic immune thrombocytopenic purpura
MONDAY, Aug. 24, 2015 (HealthDay News) -- U.S. Food and Drug Administration approval of the drug Promacta (eltrombopag) has been expanded to include children 1 year and older with chronic immune thrombocytopenic purpura (ITP).
The new approval builds on a recent approval for ages 6 years and up. Promacta has been approved for the disorder among children who have had unsatisfactory results with other drugs, or with surgery to remove the spleen, the agency said in a news release.
Promacta is designed to help increase platelet production, the FDA said. The drug, available in pill or powder form, was clinically evaluated in a trial involving 159 pediatric patients ages 1 to 17. Some 62 percent of those who took Promacta saw an improvement in platelet count, compared with 32 percent among those who took a placebo.
Promacta's most common side effects included upper respiratory infection, diarrhea, abdominal pain, rash, and an increase in liver enzymes. The drug has not been evaluated among children less than a year old, the FDA said.
Promacta is produced by Novartis, based in East Hanover, N.J.