Bayer has filed its new, first-in-class contraceptive pill Qlaira with regulators in the USA.

The German drugmaker is asking the US Food and Drug Administration to approve Qlaira (estradiol'valerate/dienogest) for oral contraception and treatment of heavy and/or prolonged menstrual bleeding. The submission comes some six weeks after Qlaira was launched in several European countries and Phil Smits, head of women’s healthcare at the company’s Bayer Schering Pharma unit, said the firm has already seen “a high interest in this new oral contraceptive by women and gynaecologists”.

Bayer has complied data involving more than 2,200 women, which showed that Qlaira was generally well-tolerated and over 99% effective in preventing unplanned pregnancy when taken as directed. The company noted that over the past 50 years, many new progestins have been developed for use in oral contraceptives, but the estrogen component remained the same - ethinylestradiol.

However Qlaira is the first drug to contain the combination of estradiol valerate - which is immediately metabolised to estradiol, equivalent to the oestrogen produced by a woman’s ovaries - with dienogest “in a unique dosing regimen”, Bayer says, “designed to deliver hormones at the right levels at the right time during the cycle”.

Bayer is a major player in contraception following its acquisition of Schering AG in 2006 and its Yasmin, Yaz and Yasminelle (drospirenone and ethinyl estradiol) brands. A US judge declared the key patent on Yasmin invalid in March last year but Bayer subsequently signed a deal with Barr to provide the latter’s generic version.

Qlaira will hopefully make up some of the lost Yasmin revenues and Bayer expects sales of 500 million euros per year. It also noted that no other oral contraceptive is approved to treat heavy or prolonged menstrual bleeding and an approval for that indication would push sales up even further.