Bayer bags first world approval for hot flush therapy

Bayer has its first regulatory approval for elinzanetant as a non-hormonal treatment for menopausal symptoms – in the UK – as it chases down a rival therapy from Astellas.

The Medicines and Healthcare products Regulatory Agency (MHRA) has cleared the oral neurokinin (NK) 1 and 3 antagonist, under the Lynkuet brand name, for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flushes), which are experienced by up to 80% of women during menopause.

The green light stems from three phase 3 studies , which showed that elinzanetant significantly reduced the frequency and severity of VMS over 12 weeks compared to placebo.

Lynkuet has become the first direct competition to Astellas' NK 3 antagonist Veozah/Veoza (fezolinetant), which was approved in the UK in December 2023 and is currently rolling out in markets around the world.

Both drugs are being positioned as alternatives to conventional hormone replacement therapy (HRT) for menopausal VMS, which can be highly effective but isn't recommended in some women, such as those who have an elevated risk of stroke, heart attack, or some forms of cancer.

"Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life," said Julian Beach, MHRA's interim executive director of healthcare quality and access. "Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies."

According to Bayer, almost two-thirds of women with menopause and VMS remain untreated despite the impact on daily activities, sleep and emotional wellbeing.

Take-up of Veozah in international markets was slow initially, but started to gather momentum last year, rocketing more than 360% to JPY 33.8 billion (around $230 million), with the US driving the increase. There is, however, still a long way to go before the drug meets Astellas' peak sales target of between $2.2 billion and $3.6 billion.

Analysts have suggested that having a second NK-acting drug in the marketplace could raise awareness and help drive the uptake of both products.

Lynkuet is viewed as a key product for Bayer, which is currently in the midst of a major restructuring drive under chief executive Bill Anderson as it deals with the loss of market exclusivity for big-selling anticoagulant Xarelto (rivaroxaban).

GlobalData recently predicted Astellas' therapy will make $1.8 billion in 2030, thanks to its first-to-market advantage, with Lynkuet making $1 billion in the same year.

Bayer said it is now waiting for additional approvals for Lynkuet and is "looking forward to bringing this option to many more women around the world."

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