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Schering AG’s menopausal symptoms drug approved in US

The FDA has approved Schering AG's drug Angeliq to treat moderate to severe menopausal symptoms. The company plans to launch the drug in the US in mid-2006.

Angeliq, already available in Europe, will be available in the US by prescription in a preparation containing 0.5mg drospirenone and 1mg estradiol.

Angeliq is different from other available hormone replacement therapy in that it contains the anti-aldosterone progestin drospirenone. Anti-aldosterone activity has been shown to counter the excess water and sodium retention sometimes caused by estrogen. In addition, Angeliq contains estradiol, the same estrogen produced by a woman’s body prior to menopause.

Angeliq was studied in large-scale clinical trials involving 1,759 women that established the safety and efficacy in providing endometrial protection and an acceptable bleeding profile among post-menopausal women.

“We have seen great success with our oral contraceptive Yasmin, which also contains drospirenone. We look forward to offering Angeliq to women in the US as a new and unique option for treating menopause symptoms,” said Dr Philip Smits, head of Gynecology & Andrology at Schering AG.