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news.The FDA has approved Daiichi Sankyo's hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults.
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Benicar is an angiotensin II receptor blocker (ARB), which blocks the action of a substance in the body called angiotensin II that increases blood pressure. It is indicated for the treatment of hypertension in adults as well as pediatric patients 6-16 years of age, alone or with other antihypertensive agents.
The company said that the approval of the expanded indication was based on a Phase III study examining the antihypertensive effects of Benicar in pediatric patients. The study found Benicar to be safe and efficacious in children ages 6-16 with hypertension, resulting in blood pressure reductions that were statistically different in comparison to placebo.
The result of the trial suggested that Benicar was generally well tolerated in pediatric patients, and the adverse event profile was similar to that for adults.