VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved QSYMIA (phentermine and topiramate extended-release capsules) CIV for use in the treatment of obesity in adolescents (12-17 years old) with an initial body-mass index (BMI) in the 95th percentile or greater standardized for age and sex. According to the CDC, approximately 22% of children aged 12-19 years in the United States — about 14 million individuals — have obesity.
The results of the QSYMIA Phase 3 trial in adolescent patients taking the top-dose demonstrated that more than 44% of patients lost at least 15% of their body weight and more than 30% of patients lost at least 20% of their body weight.
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