EU regulators okay Qlaira® for the treatment of heavy menstrual bleeding

For use outside the US only

Berlin, – Bayer Schering Pharma AG, Germany, has successfully concluded the European registration procedure for the introduction of Qlaira in the new indication treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The Netherlands served as Reference Member State for the decentralized procedure to gain Europe-wide Marketing Authorization for the new indication. Qlaira is the first in a new class of oral contraceptives to deliver estradiol, the same estrogen as the one produced by the female body. In addition, it also contains dienogest, a progestogen which is well-investigated. It has a unique dosing regimen which has been designed to deliver hormones at the right levels at the right time during the cycle. Qlaira is already marketed in over 25 European countries as an oral contraceptive.

“We’re excited by today’s news regarding the new indication for Qlaira. Heavy menstrual bleeding is a serious though under-reported condition that significantly impacts on a woman’s quality of life. Qlaira can contribute to satisfy a high unmet medical need by offering women an oral treatment option that can lead to significant reduction in menstrual blood loss,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma.

In addition to Qlaira, Bayer markets an intrauterine system Mirena® which is also approved for treatment of heavy menstrual bleeding (HMB). Both products underline Bayer’s ongoing commitment to advancing women’s healthcare by providing a choice of treatment options.

About Heavy Menstrual Bleeding (HMB)
Dysfunctional uterine bleeding is defined as abnormal uterine bleeding in the absence of organic pathology or medical illness (e.g. endometrial polyps or uterine fibroids), and is characterized by heavy menstrual bleeding (HMB), as the most commonly experienced symptom.

Prevalence studies indicate that heavy menstrual bleeding is a common symptom suffered by women of reproductive age. Studies assessing the prevalence of heavy menstrual bleeding (blood loss of 80 ml or more per menstrual cycle) using objective quantification of blood loss report a worldwide prevalence range of between 9% and 14%(1). Objective quantification of menstrual blood loss only captures one of the symptoms suffered by women with heavy menstrual bleeding, whereas subjective or self-reported assessment of heavy menstrual bleeding considers the overall impact on quality of life and is therefore likely to result in consistently higher prevalence rates(2).

(1) National Institute for Health and Clinical Excellence. Heavy Menstrual Bleeding. Costing Report. Implementing NICE guidance in England. London; 2007.
(2) Fraser IS, Langham S and Uhl-Hochgraeber K. The health-related quality of life and economic burden of abnormal uterine bleeding: A critical review; Expert Rev. Obstet Gynecol. 4(2),179-189 (2009).


About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.