Bayer receives approval for Beyaz in the U.S.

The FINANCIAL — Bayer Schering Pharma AG, Germany, has received approval from the U.S. Food and Drug Administration (FDA) for its new Beyaz.

"It is the first and only oral contraceptive (OC) approved to raise folate levels in women who choose an OC for birth control. In these women, Beyaz raises folate levels for the purpose of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking Beyaz or shortly after discontinuing it. It combines the hormone ingredients in the birth control pill YAZ with Metafolin, a stable form of the naturally occurring folate predominantly found in food. Folates belong to the group of B vitamins," Bayer informs.

“By combining one of the world’s leading birth control pills with folate, Bayer is once again at the forefront of medical innovation in reproductive health. Beyaz offers women an oral contraceptive that now also improves a woman’s folate status,” said Phil Smits, Head of the Business Unit Women's Healthcare at Bayer Schering Pharma. “Beyaz represents Bayer’s ongoing commitment to advancing the OC market paradigm by providing women with non-contraceptive health benefits beyond just birth control.”

Folate is an essential nutrient that many women of childbearing age lack. It is well established that folates play an important role during the first weeks of pregnancy. The Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, the March of Dimes and other leading health authorities recommend that all women of childbearing age supplement their diet with at least 400 mcg of folic acid daily. A well-established body of evidence supports folate supplementation as a means to reduce the incidence of neural tube defects – or birth defects of the brain and spinal cord. Folate supplementation is particularly important at least one month before and three months after conception.

Combining an oral contraceptive with folate is important, because women who discontinue OCs or do not take them correctly may become pregnant before seeking preconception counseling from their healthcare provider until after they become pregnant.

Therefore combining an oral contraceptive with folate is a significant medical advance.

Beyaz is the first and only birth control approved by the FDA for four indications:

• Prevention of pregnancy (99% effective when taken as directed)

• Treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose an oral contraceptive for birth control

• Treatment of moderate acne for women at least 14 years of age, who choose an oral contraceptive for birth control, and have started having menstrual periods

• To raise folate levels in women who choose an oral contraceptive for birth control, for the purpose of potentially reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product

Beyaz is taken in a 24/4 day regimen consisting of 24 days of 3 mg drospirenone / 20 mcg ethinyl estradiol with Metafolin (levomefolate calcium 451 mcg) followed by four days of Metafolin® only. Beyaz is expected to be available in the U.S. in October by prescription only.