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news.Wyeth has received an approvable letter from the FDA for its oral contraceptive Lybrel, stating that the drug candidate cannot be approved until additional data are submitted.
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Wyeth is seeking marketing approval for Lybrel, an investigational low dose combination oral contraceptive for women have no known contraindications for this method of contraception.
If approved, this investigational product will contain a low daily dose of ethinyl estradiol and levonorgestrel, a well-studied combination. It is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval.
In response to the approvable letter, Wyeth said that it will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data.
The FDA also indicated that it plans to convene a public meeting of contraceptive experts this year to discuss the clinical aspects of Lybrel. The anticipated topics include a review of the US Pearl Index (a calculation of the pregnancy rates among study participants), bleeding patterns, and the discontinuation rate among women in the study.
“Wyeth is confident that we can address the questions raised by the FDA, and we expect to move toward the launch of Lybrel,” said Dr Gary Stiles, executive vice president and chief medical officer of Wyeth Pharmaceuticals.