US FDA approves Bayer's oral contraceptive Natazia
This article was originally published in Scrip
The US FDA has approved Bayer's oral contraceptive Natazia (estradiol valerate and estradiol valerate/dienogest). A launch is planned for this summer.
The product, which is already marketed in Europe under the trade name Qlaira, is the first contraceptive to contain the oestrogen estradiol valerate, which is immediately metabolised in the body to estradiol, the oestrogen produced by the ovaries. All other combined oral contraceptives contain the oestrogen pro-drug ethinylestradiol, Bayer notes.
It also contains the progestin dienogest, and is the first four-phasic oral contraceptive to be marketed in the US, the FDA said. Four-phasic refers to the doses of progestin and oestrogen varying at four times throughout each 28-day treatment cycle. Natazia also does not require a seven-day pause in treatment, which some women may prefer, and provides another contraceptive option, Bayer said.
The product's approval is based on two multicentre Phase III clinical trials in North America and Europe that enrolled 1,867 women in which Natazia was found to be effective as a hormonal contraceptive in both studies.
menstrual bleeding indication
Natazia was also filed in the US as a treatment of heavy and/or prolonged menstrual bleeding (menorrhagia), but has yet to be approved for this indication. Bayer said it was in ongoing dialogue with the FDA, which has said that no further clinical trials are needed to gain the label extension. The company expects receive a verdict from the agency in the near future.
Even though oral contraceptives are commonly used to control menstrual bleeding, Natazia would be the first product to carry the indication on its label should it secure an approval. This will help differentiate it from other contraceptives, both generic and branded, that are already on the market. Bayer's intrauterine device Mirena (levonorgestrel-releasing intrauterine system) received approval for menorrhagia last year.
An EU filing for Qlaira for the treatment of heavy and/or prolonged menstrual bleeding is also expected this year.