Bayer get EU nod for extended use of contraceptive Mirena
Bayer's big-selling contraceptive Mirena has been approved in Europe to provide up to eight years of pregnancy protection, which the company says is the longest of any device of its kind.
The approval under the European Workshare Procedure also covers use of Mirena for the treatment of idiopathic menorrhagia (heavy menstrual bleeding) for up to eight years, according to the pharma group.
The EU decision follows a green light from the FDA for longer-duration use of Mirena – an intrauterine device (IUD) that also delivers the hormone levonorgestrel – in August. It was first approved for five-year contraception back in 2000, and had that extended to seven years in 2021.
Now, the label says it "should be removed or replaced after eight years at the latest," according to Bayer.
The label extensions come on the back of a clinical trial involving around 3,330 women that showed that Mirena's contraceptive efficacy remains high, at more than 99% during years six to eight years of use.
The cumulative pregnancy rate at the end of the three-year period of extended use – i.e. years six, seven, and eight – was 0.68%, according to the data. That compares to 0.1% in the first year of use, and 0.7% in the first five years.
Following the completion of the European Workshare Procedure, the first national approvals in the EU are expected before the end of the year.
Mirena is one of Bayer's top products, heading a contraceptive franchise that generated around €600 million ($583 million) for the company in the first six months of the year.
Bayer's contraceptive sales have been depressed during the pandemic, but have been "slowly coming back" in 2022, according to Stefan Oelrich, head of the company's pharma division.
Contraceptives are its third biggest-selling pharma category after anticoagulant Xarelto (rivaroxaban) and ophthalmic disease treatment Eylea (aflibercept), both of which are facing patent expirations before the end of the decade.
"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, Bayer's chief medical officer.
Approximately 17% of women of reproductive age (around 160 million worldwide) use intrauterine contraception, including hormone-releasing products. It is held up as one of the most effective birth control methods, as it does not require user compliance such as daily dosing or monthly refills.