Daiichi Sankyo's Benicar receives FDA approval for hypertension treatment in children and adolescents aged 6-16

Feb 11 2010

Daiichi Sankyo, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the 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.  

Approximately 5 percent – or 3.6 million – American children suffer from high blood pressure, with the majority unaware they have the condition. Studies have also found that the average blood pressure of American children is on the rise, in parallel with the increase of children's weight.  In fact, an analysis of nearly 40 years of national surveys of high blood pressure trends in children and adolescents showed that the prevalence of elevated blood pressure among this group has been growing since the late 1980's.

"As hypertension is on the rise also in a younger population, Daiichi Sankyo believes it is important to help doctors meet the challenge of treating these pediatric patients by providing a treatment option to help people effectively manage their hypertension," said Reinilde Heyrman, MD, Vice President Clinical Development – Operations, Daiichi Sankyo Pharma Development.

Pediatric hypertension is closely linked to childhood obesity, as obese children are at approximately a three-fold higher risk for hypertension than non-obese children.  Additionally hypertension during childhood has been shown to be an independent risk factor for hypertension in adulthood, and to be associated with early markers of cardiovascular disease, making it important to treat this condition in children and adolescents.

The approval of this 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. Benicar was generally well tolerated in pediatric patients, and the adverse event profile was similar to that for adults.

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.