Bayer oral contraceptive gets first EU approval

Yaz (3 mg drospirenone/20 mcg ethinyl estradiol), an orally-administered contraceptive from Bayer Schering Pharma, has been approved by the regulatory bodies in the Netherlands.

The country is to act as a reference member state for the forthcoming mutual recognition procedure that will result in marketing approval being granted for the drug across the European Union.

Already approved in the US, the compound has been clinically proven to treat symptoms associated with premenstrual dysophoric disorder, including anxiety, changes in appetite, breast tenderness, headache, bloating and irritability, with Bayer Schering Pharma to pursue European approval for this indication.

Bayer Schering Pharma notes that the compound contains the drospirenone, a novel progestin that exhibits antimineralcorticoid and antiandrogenic properties, making the drug dissimilar to other progestins available on the market in oral contraceptives.

Phil Smits, head of women’s healthcare at Bayer Schering Pharma, said: “We are very excited about this first European approval for Yaz.

“Yaz is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen.”

He added that the compound offers women wanting a reliable method of birth control a number of additional benefits, such as the treatment of acne.

The monophasic oral contraceptive received marketing approval from the US Food and Drug Administration in March 2006, when the drug was presented to the body by Schering.