Bayer has received the green light from regulators in the USA for its combination oral contraceptive Natazia.

The US Food and Drug Admininstration has approved Natazia, a combination hormonal tablet which contains two female hormones, an estrogen (estradiol) and a progestin (dienogest) and sold in Europe as Qlaira since a year ago. The agency noted that this is the first four-phasic oral contraceptive marketed in the USA, ie the doses of progestin and estrogen vary at four times throughout each 28-day treatment cycle.

The approval is based on two Phase III clinical trials in North America and Europe involving 1,867 women and nearly 30,000 28-day treatment cycles. Scott Monroe, director of the FDA’s Division of Reproductive and Urologic Products, noted that nearly 12 million women in the USA currently use oral contraceptives and “the approval of Natazia provides another option”. The agency noted that women older than 35 who smoke should not use the product.

Bayer has previously said that annual sales of the drug in the USA could reach 500 million euros and it will be hoping that Natazia will make up some of the recent revenue declines suffered by its Yaz/Yasmin/Yasminelle (drospirenone and ethinyl estradiol) contraceptive franchise due to the thrombosis risk of contraceptives containing drospirenone and the threat of generic competition.

Meantime, the Leverkusen-headquartered group has begun a Phase III trial to evaluate regorafenib, also known as BAY 73-4506, for the treatment of patients with metastatic colorectal cancer who have progressed after standard therapies.

The CORRECT study will enroll 690 patients with metastatic CRC who have progressed after standard therapies who will be randomised to receive either regorafenib plus best supportive care or placebo plus BSC. The drug is an oral multi-kinase inhibitor like Bayer’s Nexavar (sorefenib); the German firm’s partner for the latter drug, Onyx Pharmaceuticals, is suing over the rights to regorafenib but Bayer believes the substance is not covered by their collaboration.