Fezolinetant

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.

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.The study, known as Oasis-4, is the fourth successful trial test of Bayers drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncologys annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.Vasomotor symptoms include hot flashes and disrupted sleep, and are typically associated with menopause. However, these symptoms can occur in almost 90% of women with early breast cancer who are treated with endocrine drugs. The side effects are disruptive enough to sometimes cause breast cancer patients to stop treatment, which could affect disease progression and, ultimately, survival.In women experiencing menopause, hormone-replacement therapies can be used to treat vasomotor symptoms. But in women with early-stage breast cancer, those same treatments can increase the risk of their disease worsening or returning.With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options, said Fatima Cardoso, the studys lead investigator and the director of the breast cancer unit at the Champalimaud Cancer Center in Lisbon, Portugal, in a statement provided by Bayer.Elinzanent provides a non-hormonal option. The drug targets two receptors, NK1 and NK3, that help regulate body temperature. In Oasis-4, 316 participants were randomly assigned to take elinzanetant once daily, while 157 received placebo. Vasomotor symptoms were assessed at one and three months. After 12 weeks, people who had been given placebo were switched to elinzanetant for the remainder of the main one-year evaluation period.Results showed that elinzanetant quickly alleviated symptoms at both weeks 4 and 12 compared to placebo, meeting the studys primary goal. After one month, 61% of women taking the Bayer drug reported the frequency of daily moderate-to-severe vasomotor symptoms had been reduced by at least half. And at three months, women taking the drug experienced greater improvements in sleep and quality of life compared to those on placebo.Trial participants who switched to elinzanetant after taking a placebo for 12 weeks also experienced similar benefits.It's due time that new innovation comes into this space, said Yesmean Wahdan, vice president of U.S. medical affairs for Bayers womens health unit, in an interview with BioPharma Dive. [This therapy] really aims at targeting the source of what's causing the symptoms that are happening as the woman goes through the menopausal transition and into menopause.The Oasis-4 results were also published in The New England Journal of Medicine Monday.Last year, Bayer unveiled data from a Phase 3 study of women taking elinzanetant for vasomotor symptoms associated with menopause. The drug proved efficacious among this group of women as well, supporting an application by Bayer for approval.[Menopause] is a condition many women will enter into and face no matter where you are in life, Wahdan said. Some enter it via clinical reasons. They're put on medications, they have surgery. And some of us enter it as a transition in life.If approved in women with vasomotor symptoms as a result of their breast cancer treatment, elinzanetant would be the first therapeutic of its kind.It's a therapy that is targeted at all women who are experiencing these [vasomotor] symptoms, Wahdan said. We know that [women taking endocrine therapy] have, for a long time, been excluded from some of the more traditional therapies for symptoms of menopause.One approved non-hormonal option for vasomotor symptoms comes from Japanese pharmaceutical company Astellas Pharma, but it is not approved for women being treated for breast cancer. Called Veozah, the drug has struggled commercially due to weaker-than-expected demand and reimbursement issues. The Food and Drug Administration also recently added a safety warning for possible liver damage to the drugs labeling.In Oasis-4, almost 70% of women taking elinzanetant reported at least one adverse event, versus 62% of those in the placebo group. There were serious adverse events reported in eight women treated with Bayers drug. Most commonly, however, side effects were fatigue, headache and drowsiness.In an editorial published in NEJM, Ann Partridge, interim chair of the Dana-Farber Cancer Institutes medical oncology department, noted that a better understanding of elinzanetants side effects will be essential to incorporating the drug in patient care.Reassuringly, the present trial and previous trials of elinzanetant have shown no increased risk of toxic effects on the liver, which have been reported in rare cases with another agent in this class, she wrote, referring to Veozah. '