Bayer’s contraceptive Mirena approved in Europe for extended duration

Bayer has announced that it has positively concluded the European Workshare Procedure extending the duration of use for up to eight years in contraception of its device in Europe.

Mirena is a T-shaped intrauterine device (IUD) containing 52 mg of synthetic levonorgestrel – a hormone that thickens the mucus in the cervix to stop egg fertilisation and partially suppresses ovulation.

Bayer’s regulatory approval in Europe is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of Mirena which demonstrated that contraceptive efficacy remains high with greater than 99 per cent during years six to eight of use.

Following the completion of the European Workshare procedure the first national approvals in the EU are expected in Q4 2022.

‘With the positive clearance of the approval process in Europe we are pleased to be able to offer soon the extended label also to women in Europe and with this enriching the range of contraceptive methods as individual contraceptive needs are changing throughout the reproductive life,” said Dr Michael Devoy, chief medical officer at Bayer AG.

The European approval also includes symptom driven extended use for the indication idiopathic menorrhagia – heavy menstrual bleeding – for up to eight years or until symptoms return.

The IUS should be removed or replaced after eight years at the latest.

The news follows the US FDA’s decision in August to approve Mirena for longer-duration use.

A LNG-IUS is one of the most effective birth control methods as it does not require user compliance such as daily dosing or monthly re-fills.

It can be removed by the doctor and offers a rapid return to a woman’s natural level of fertility after removal.

According to the pharma group, the contraceptive efficacy of Mirena for up to five years has been studied in five large clinical trials involving 3,330 women.

Once placed in the uterus, the device continuously releases small amounts of levonorgestrel directly into the uterus, but it can be removed any time by a healthcare provider.