Wyeth's Lybrel approved by FDA

USA-based drug maker Wyeth says that its oral contraceptive Lybrel (90mcg levonorgestrel/20mcg ethinyl estradiol) has been approved by the Food and Drug Administration. The firm explained that the product was developed as a low-dose hormone-based agent designed to be taken 365 days a year, without the need for a placebo phase or pill-free interval.

Wyeth said that the FDA's decision was based on efficacy results from trials of the drug involving 2,457 women worldwide. The firm also said that the occurrence of breakthrough bleeding and spotting events, 21% and 20%, respectively, had been shown to decrease over time, adding that around 59% of study participants had achieved amenorrhea.

For its part, the FDA said that Wyeth had satisfied the additional requirements laid out in an "approvable letter" issued last summer (Marketletter July 10, 2006). The agency noted that expert guidance from its Reproductive Health Drugs advisory committee, and an opportunity for public comment, were included in its review of the drug.