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.
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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.
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