German drugmaker Schering AG’s US affiliate, Berlex Laboratories, has been granted approval to market its hormone therapy, Angeliq (drospirenone and estradiol), for the treatment of menospausal symptoms.
The agent is different from other available hormone replacement therapies as it contains drospirenone, which has been shown to buffer the excess water and sodium retention sometimes caused by oestrogen. In addition, Angeliq contains estradiol, the same type of estrogen produced in women prior to menopause, the group noted.
“Angeliq provides menopausal women and healthcare professionals with a new treatment option containing the progestin, drospirenone, which is also found in Yasmin, the number-one brand of oral contraceptive in the USA and worldwide," commented Reinhard Franzen, President and Chief Executive Officer of Berlex Laboratories. Schering reported a 56% jump in sales of Yasmin to 429 million euros for 2004, making it the world's leading oral contraceptive, according to the firm [[09/02/05b]].
Approval of the agent was based on the results of several large-scale clinical trials, involving more than 1,759 postmenopausal women, which demonstrated its safety and efficacy in treating moderate-to-severe vasomotor symptoms, including hot flashes, night sweats and vulvar and vaginal atrophy, usually within four weeks of therapy, the group said.
Angeliq’s road to approval has not been smooth. An FDA approvable letter last year requesting additional marketing information [[16/09/04c]] followed an earlier knock-down in 2002 [[21/10/02d]] before the submission of additional data, reflecting the agency’s caution over hormone replacement therapies at that time.