Bayer gets EU approval for menopause drug Lynkuet

Bayer now has approval on both sides of the Atlantic for Lynkuet, a non-hormonal treatment for vasomotor symptoms (VMS) that the company considers one of its top growth prospects.

The oral neurokinin (NK) 1 and 3 antagonist has been cleared by the European Commission for moderate to severe VMS associated with menopause or endocrine therapy for breast cancer, around a month after the FDA gave its blessing to the menopause indication in the US.

Lynkuet (elinzanetant) is the first direct competition to Astellas' NK 3 antagonist Veozah/Veoza (fezolinetant), which is currently approved for menopause-related VMS only, first approved in 2023.

While initial uptake of the product was fairly slow, there are signs of momentum building, with Astellas saying last month that sales of the drug in the first six months of the current fiscal year had grown by nearly 55% to around $146 million.

However, the FDA's addition of a warning of rare, but serious, liver injury on its label has pegged back peak sales expectations, while Lynkuet has also been associated with increased liver enzyme levels and patients taking it are advised to have regular blood tests to monitor liver function.

Bayer has billed Lynkuet as its next major pharma launch, saying it is due to start rolling out in the US later this month, and analysts have also said they anticipate blockbuster sales for the product. So far, it has been approved in the US, EU, UK, Australia, Canada, and Switzerland.

The target population for Lynkuet is huge, with 1.2 billion women globally expected to be experiencing menopause by 2030. Meanwhile, millions of women are diagnosed with breast cancer every year, and 70% have HR-positive tumours that are treated with endocrine therapies and expose them to VMS as a side effect.

"Menopause symptoms, including hot flashes, can greatly affect women's quality of life," commented Nick Panay, a gynaecologist at Imperial College London in the UK, who was principal investigator in one of the clinical trials that supported Lynkuet's approval.

"This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalised treatment," he added.

One possible confounder for Lynkuet is the FDA's recent decision to remove 'black box' warning labels for breast cancer, cardiovascular disease, and dementia on hormone replacement therapies (HRT) for menopause, which could encourage greater use of hormonal therapies and limit the potential of newer options like Veoza and Lynkuet.