Bayer Schering Pharma AG, Germany, has announced that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ, which is 3 mg drospirenone/20 mcg ethinyl estradiol in the Netherlands.
YAZ will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.
"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. Through its innovative active ingredient drospirenone, YAZ offers additional benefits, such as the treatment of acne, to women who want reliable birth control," said Phil Smits, MD, head of Women's Healthcare at Bayer Schering Pharma AG.
YAZ has been available in the US since April 2006, is the fastest-growing oral contraceptive brand in the US. YAZ is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.
Like Yasmin, the number one brand birth control pill worldwide, YAZ contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone's antiandrogenic action, YAZ can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).
YAZ has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone's benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.