Bayer has been given a green light in the EU for its low-dose levonorgestrel-releasing intrauterine system as a means to prevent pregnancy.
The firm has now successfully completed the European registration procedure to gain EU-wide marketing authorisation for its long-acting contraceptive Kyleena, which provides protection for up to five years.
The product was approved in the US in September on the back of data showing a very low rate of pregnancy rate in women who had the system (e.g. 0.16 in year 1 and 0.37 in year 5).
However, 22 percent of women discontinued due to adverse events, because of increased bleeding (4.5 percent), abdominal pain/pelvic pain (4.2 percent), device expulsion (3.1 percent), acne/seborrhea (2.3 percent), and dysmenorrhea/uterine spasm (1.3 percent).
It is expected that national EU authorities will now issue marketing authorisations in the coming weeks and months.
