Wyeth’s Lybrel gets FDA nod

The FDA today approved Wyeth’s new birth control pill Lybrel, which can halt women’s menstrual periods indefinitely. Wyeth said it plans to start sales of Lybrel in July. The company has yet to announce the drug’s cost. The drug comes in a 28 day-pill pack with low-dose combination tablets that contain 90 micrograms of levonorgestrel and 20 micrograms of ethinyl estradiol, which are active ingredients available in other approved oral contraceptives. Industry analysts estimate Lybrel sales could reach $40 million by the end of 2007 and $235 million by 2010. Lybrel is the first oral contraceptive to be taken continuously and is designed to eliminate menstrual bleeding. Other oral contraceptives, such as Bayer’s Yaz and Warner Chilcott’s Loestrin 24, shorten monthly periods to three days or less, and Duramed’s Seasonique, an updated version of Seasonale, reduces them to four times a year. Yaz, launched last August, had US sales of around $35.6 million in the first-quarter of 2007. Loestrin 24, launched in April 2006, had US sales of $34.4 million in the first-quarter. Sales of Seasonique, launched last August, were at $6.1 million in the first-quarter. In a statement issued this afternoon, the FDA advised health care professionals and patients that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting. The occurrence of unscheduled bleeding decreases over time in most women who continue to take Lybrel for a full year, agency officials said. In the primary clinical study of Lybrel, 59% of the women who took the oral contraceptive for one year had no bleeding or spotting during the last month of the study, regulators said.