US regulators have given the all clear to Bayer HealthCare Pharmaceuticals’ new oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets), the first birth control pill to be approved with four different indications.
Beyaz is comprised of the hormone components of Bayer’s veteran oral contraceptive (OC) YAZ and 451mcg of the B vitamin levomefolate calcium, and the drug has been given the nod for the prevention of pregnancy and treating symptoms of premenstrual dysphoric disorder and moderate acne in women using the ‘pill’ for birth control.
But what really differentiates Beyaz from the rest of the pack is its ability to raise folate levels, and thereby reduce the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing its use.
A wealth of evidence exists in support of folate supplementation as a means of reducing brain and birth defects - which happen in the very early stages of pregnancy and so often before a woman is aware she has conceived - and the company is hoping that a contraceptive pill also able to boost levels of folate will have a competitive edge over its rivals and thereby breathe new life into its franchise.
“Combining an oral contraceptive with folate is important, because women may become pregnant during OC use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare provider,” explained Anita Nelson, Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California, and she added Beyaz offers “a new option for women to receive daily folate supplementation”.
FDA clearance of Beyaz is based on evidence from a comprehensive clinical trial programme backing its use in each of its four approved indications. A pivotal clinical involving 379 healthy women aged 18-40 years showed that the drug was able to significantly raise levels of folate from baseline compared to its predecessor YAZ, while the other three indications are supported by five clinical trials involving the older contraceptive, the firm said.
Beyaz should be on the market next both and will be available by prescription only.