Bayer wins FDA approval for new indication of intrauterine contraceptive

Tue. October 06, 2009; Posted: 08:40 AM

Oct 06, 2009 (Datamonitor via COMTEX) -- BAYRY | Quote | Chart | News | PowerRating -- Bayer HealthCare Pharmaceuticals has received the FDA's approval for a new indication for Mirena for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Bayer HealthCare Pharmaceuticals is the US-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG.

According to Bayer HealthCare Pharmaceuticals, Mirena provides an effective, non-surgical option for the treatment of heavy menstrual bleeding and is the first and only contraceptive approved in the US for this indication.

The FDA approval is based on data from a randomized, open-label, active-control, parallel-group clinical trial of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause heavy menstrual bleeding, with the exception of small uterine fibroids in some patients.

Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of greater than or equal to 80mL, was determined using the alkaline hematin method. In the study, Mirena (n=79) was compared to an approved first-line hormonal therapy, medroxyprogesterone acetate (n=81), over six menstrual cycles.

According to the company, Mirena is a removable intrauterine contraceptive that delivers small amounts of hormone directly to the uterus.

Stefan Oelrich, vice president and general manager of women's healthcare at Bayer HealthCare Pharmaceuticals, said: "Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. We are pleased to now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an intrauterine device for contraception."

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