Benicar Gains New Approval

Daiichi Sankyo, Inc. received approval from the FDA for its hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age.

“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, M.D., vice president clinical development, operations, Daiichi Sankyo Pharma Development.

The approval was based on a Phase III study examining the antihypertensive effects of Benicar in pediatric patients. The study found the drug to be safe and effective in children ages 6-16 with hypertension, resulting in statistically significant blood pressure reductions compared to placebo. Benicar was originally approved for the treatment of hypertension in adults in 2002.