Bayer Obtains Market Clearance for New Oral Contraceptive in Europe
Bayer Schering Pharma, a specialty pharmaceutical company, has completed the decentralized drug approval procedure in Europe for its new oral contraceptive Qlaira.
Qlaira is an oral contraceptive whose estrogen component is based on estradiol, the same estrogen that is produced by the female body. With Qlaira, Bayer Schering Pharma offers women a new choice of estrogen and establishes a new class of oral contraceptives.
For the first time, the use of estradiol in oral contraceptives is made possible with Qlaira through the combination of estradiol with the progestin dienogest in a unique dosing regimen, the company said.
According to the company, the combination of estradiol and dienogest in a unique dosing regimen ensures good cycle control and reliable contraception. Clinical studies have shown that the new combination’s bleeding control is as good as that of oral contraceptives containing 20 micrograms of ethinyl estradiol.
Bayer Schering Pharma is also developing Qlaira for the treatment of excessive, prolonged, and frequent menstrual bleeding (dysfunctional uterine bleeding). Approval of Qlaira for this additional indication would represent another important milestone; no other contraceptive has yet been approved for treating this disease.
Phil Smits, head of women’s healthcare at Bayer Schering Pharma, said: “We are very proud that once again, only months after the approval for our low-dose oral contraceptive YAZ in May 2008, we reached another milestone with the successful closure of the decentralized procedure for Qlaira in Europe. Qlaira is the first oral contraceptive providing a body-identical estrogen.”