Schering AG, Germany announced that the European Union has positively concluded the Mutual Recognition Procedure for Schering's novel low dose hormone replacement therapy (HRT) product Angeliq. After the decision is made, the European member states usually get the official certificate of approval within three months. The rollout of the pan European launch for Angeliq will begin this autumn. Schering received the first European approval for Angeliq in December 2002 in the Netherlands, which served as the reference member state for the Mutual Recognition Procedure (MRP).
"We welcome the broad European registration, which confirms the confidence of the health authorities in Angeliq. Not only can Angeliq enhance the quality of life of women suffering from menopause by alleviating symptoms, but it also has unique antialdosterone properties, thereby lessening water retention many women experience," said Professor G|nter Stock, Member of the Executive Board of Schering AG responsible for Research and Development. "It also shows that different progestins have different actions and profiles. Hence Angeliq is a new and different option for women and physicians, who are looking for a low dose and innovative treatment for menopausal symptoms."
Angeliq is a low-dose combination preparation and the only HRT product which combines estradiol with the unique progestin drospirenone, developed by Schering. It is indicated for the treatment of menopausal symptoms and the prevention of osteoporosis in postmenopausal women.
Drospirenone is significantly different from other progestins available in hormone replacement therapy. Drospirenone's pharmacological profile mimics the hormone progesterone, one of the hormones naturally occurring in a woman's body. It inhibits the effect of aldosterone, the adrenal cortical hormone, which regulates the body's sodium and water balance. Hence, drospirenone counteracts water retention that estrogen and many synthetic progestins can cause.