Bayer receives EU approval for long-lasting contraceptive Kyleena

Bayer has been granted European regulatory approval for Kyleena, its new low-dose levonorgestrel-releasing intrauterine system (IUS).

The new long-acting contraceptive system has successfully concluded the European registration procedure, following on from its US approval last month. It will commence its commercial rollout in Europe early next year.

Kyleena releases the lowest daily dose of the hormone levonorgestrel in an IUS made for up to five years of effective protection against pregnancy, using the smallest T-body in an IUS currently on the market.

Long-acting contraception is increasingly seen as one of the most effective methods of birth control, as it does not require user interventions such as daily dosing or monthly refills. The IUS can be removed at any time without affecting the woman's natural level of fertility.

Dr Joerg Moeller, member of the executive committee of Bayer's pharmaceuticals division and head of development, said: "Our scientists and clinicians have intensely worked on new low-dose long-acting contraceptives in the last decades as more and more women worldwide seek this form of contraception."

Health authorities in the EU member states are expected to grant national marketing authorisations to the new product in the coming weeks and months.

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