An FDA advisory committee voted 14 to two to recommend FDA approval of Agile Therapeutics’ birth control patch AG 200-15 (levonorgestrel/ethinyl estradiol).
The drug’s safety and efficacy are “similar, if not better” than current products on the market, noted Monica Christmas, an assistant professor in the department of obstetrics and gynecology at the Washington University School of Medicine.
Results of a phase 3 clinical trial, which included obese and ethnically diverse women, showed that the patch reduced the risks of pregnancy with a 5.83 percent failure rate. But the failure rate was 8.64 percent in obese women, who were also shown to be at greater risk of developing blood clots.
The company proposed adding a Limitation on Use to the labeling to indicate that efficacy and safety are reduced when used by women over 202 pounds with a body mass index of at least 30.