Fezolinetant

The UK is the first in the world to approve Bayer’s non-hormonal treatment for hot flashes, as the company awaits a decision from the FDA. The UK’s Medicines and Healthcare products Regulatory Agency approved elinzanetant this week to treat moderate to severe vasomotor symptoms, otherwise known as hot flashes, caused by menopause. The drug will be marketed in the UK as Lynkuet, Bayer announced on Thursday. Bayer previously said it hoped to launch the drug in the US in the second half of this year. A Bayer spokesperson did not immediately respond to requests for comment on the FDA’s expected timeline or Lynkuet’s price in the UK. Hot flashes are caused by certain brain cells that become overactive when estrogen levels decline during menopause. Elinzanetant works by “calming those signals in the brain,” MHRA said in a Tuesday press release . “Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,” Julian Beach, interim executive director of healthcare quality and access at MHRA, said in the release. “Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.” Lynkuet will compete with Astellas’ Veozah, which was approved in the US and UK in 2023 and has a similar underlying mechanism. Veozah (marketed as Veoza in the UK) targets a receptor called neurokinin 3, or NK3, which is involved in the brain’s regulation of body temperature. Bayer’s elinzanetant also targets NK3, as well as another receptor called NK1.

Bayer announced on Thursday that its treatment for vasomotor symptoms (VMS) associated with menopause was greenlit by UK regulators, marking its first-ever approval and setting Lynkuet (elinzanetant) up to compete with a similar drug from Astellas. The Japanese pharma's neurokinin (NK)-3 receptor antagonist fezolinetant, cleared in 2023 by the FDA as Veozah and in Europe as Veoza, had high expectations as the first nonhormonal treatment for VMS, but it underperformed at launch — and a liver safety signal has hampered sales. For further analysis, see Spotlight On: Astellas’ liver tox pain with Veozah could be Bayer’s gain in VMS and ViewPoints: With incoming rival on horizon, Astellas charts Veozah's voyage to remain market leader.Those setbacks could provide an opening for Bayer's entrant to stake its claim in the menopause space. Lynkuet, a dual NK-1/NK-3 receptor antagonist, doesn't appear to be saddled with the same liver monitoring requirements as Veoza. Plus, given its long history as a women's health company, Bayer could be better equipped to improve physician awareness of the drug class, Christine Roth, executive vice president of global product strategy and commercialisation at Bayer, told FirstWord in a recent interview. She added that Bayer has "a very robust awareness campaign ready to go" in the US, where  an FDA decision is expected by July 26. For more on that conversation, see ViewPoints: Bayer hoping elinzanetant can change the VMS narrative.Hot flash rates slashedThe UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved Lynkuet based on the results of three trials within Bayer's Phase III OASIS programme, which involved over 1400 women aged 40 to 65 randomised to take a daily 120-mg tablet of Lynkuet or placebo. The OASIS 1 and 2 studies, published in JAMA last year, showed significant reductions in VMS frequency and severity over 26 weeks, with over 80% of participants in the Lynkuet group achieving a reduction in their VMS frequency of at least half by week 26.For OASIS 3, women taking Lynkuet saw a similar drop in hot flashes; at baseline, the group experienced around 6.7 hot flashes per day, which fell to a rate of 1.6 per day after 12 weeks of treatment. Bayer reported that no signals of hepatotoxicity were observed even after one year of treatment in OASIS 3.