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Bengaluru: The U.S. Food and Drug Administration has approved Bayer's drug to ease hot flashes in menopausal women, the German company said on Friday, a welcome development following the regulator's three-month review extension. The drug, branded as Lynkuet , is a non-hormonal treatment designed to relieve moderate-to-severe vasomotor symptoms, also known as hot flashes, associated with menopause. Bayer said Lynkuet, a once-daily capsule to be taken at bedtime, is expected to be available in the U.S. beginning November. The drug's wholesale cost is $625 for a month's supply, though patient costs vary based on insurance, the company said. It has partnered with online pharmacy BlinkRx, through which eligible patients may pay as little as $25 a month via the Lynkuet Access, Savings and Support program. The FDA's approval for Lynkuet was based on three late-stage studies that showed the drug reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women. Bayer has been gearing up to launch the drug this year, projecting annual peak sales of at least $1 billion, a strategic move to bolster its pharmaceuticals business amid mounting debt pressures. Its label, however, warns about possible drowsiness, increases in liver enzymes, risk of pregnancy loss, and seizures in people with a seizure history. Patients are advised to avoid grapefruit during treatment, Bayer said. The drug is already approved in Australia, Canada, the UK and Switzerland. An application is pending in the European Union. Japanese drugmaker Astellas' non-hormonal, oral treatment Veozah is the other approved treatment in the U.S. for hot flashes associated with menopause. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar)

Bayer plans to launch Lynkuet in the U.S. starting next month. Following its first approval in the U.K. in July, Lynkuet has also crossed the regulatory finish line in Australia, Canada and Switzerland. Following a slight delay earlier this year—and a world-first green light in the U.K. over the summer—Bayer has clinched an FDA nod to bolster the limited arsenal of nonhormonal treatments for some of the most common symptoms of menopause.Friday, the FDA approved Bayer’s dual neurokinin (NK) targeted therapy elinzanetant, which will now be marketed in the U.S. under the brand name Lynkuet, to treat moderate to severe vasomotor symptoms—comprising hot flashes and night sweats—in people with menopause.Lynkuet comes in a soft gel capsule and is taken once a day at bedtime, Bayer noted in an Oct. 24 press release. The drug is designed to target both the NK1 and NK3 receptors in the brain, which play a role in temperature regulation, the German drugmaker explained.Bayer plans to launch Lynkuet in the U.S. starting next month. Following its first approval in the U.K. in July, Lynkuet has also crossed the regulatory finish line in Australia, Canada and Switzerland. The drug is currently undergoing reviews in the EU and several other jurisdictions.Now, with clearance to hit the U.S. market, Lynkuet will soon show down with Astellas’ Veozah, another nonhormonal menopause symptom drug that targets NK3 but not NK1. Veozah passed muster with the FDA in May 2023. Women with menopause also have access to a third nonhormonal treatment in the U.S. in Brisdelle, a reformulation of the decades-old antidepressant paroxetine that was cleared to control hot flashes back in 2013.Aside from those options, hormone therapy incorporating estrogen alone or with progesterone has long been a benchmark treatment for vasomotor symptoms. Nevertheless, hormone-based therapies aren’t necessarily a good fit for all women, and they carry known risks such as endometrial and breast cancers.Up to 80% of women report having hot flashes at some point during the menopausal transition, and the symptom is one of the main factors that prompts women to seek menopause treatment, Bayer explained in its U.K. approval announcement earlier this year. More than one-third of women report experiencing severe vasomotor symptoms, which can last a decade or more after the last menstrual period, the company has said.By 2030, Bayer estimates that the global population of women experiencing menopause will increase to 1.2 billion, with some 47 million women entering this stage in their life each year.Bayer backed up its FDA approval submission with a trio of late-stage studies.In the studies Oasis 1 and Oasis 2, Lynkuet significantly reduced the average frequency and severity of moderate to severe hot flashes compared to placebo at the four- and 12-week marks. Meanwhile, more than 80% of patients who received Lynkuet achieved at least a 50% reduction in vasomotor symptom frequency by Week 26 of Bayer’s studies. The trials also showed statistically significant improvements in sleep disturbances and a menopause-related quality of life measure compared to a dummy drug, according to Bayer.The drug’s safety was assessed in those two studies, as well as a third trial dubbed Oasis 3, in which 627 women received Lynkuet or placebo for up to a year to gauge the medicine’s long-term safety, Bayer noted in its approval announcement.Bayer’s drug may end up holding an edge over Veozah when it comes to safety or perceptions about safety, given that the latter drug from Astellas currently carries a black box warning for potential liver damage while Lynkuet does not. The most common side effects Bayer observed in its trials were headache, fatigue, dizziness, drowsiness or sleepiness, stomach pain, rash, diarrhea and muscle spasms.That said, the drugmaker did caution that Lynkuet can cause serious side effects like “daytime impairment,” increased liver blood test values, risk of pregnancy loss and seizure risk in people with a history of seizures. The drug should not be taken by pregnant women, Bayer added.“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” Claire Gill, president and founder of the National Menopause Foundation, said in Bayer’s announcement. Bayer’s FDA thumbs-up follows a brief delay earlier this year, when the FDA pushed back its target decision date on the medicine by up to 90 days. At the time, Bayer stressed that the FDA needed additional time to review the filing but had not raised any concerns about the “generally approvability” of Lynkuet. Bayer has projected that peak sales for the drug could reach 1 billion euros ($1.16 billion) annually.As for Veozah, the drug did not perform quite as well last year as Astellas had hoped. For the 2024 Japanese fiscal year, the NK3 receptor agonist reached sales of 33.8 billion Japanese yen (around $221.25 million), which fell below Astellas’ projections.Earlier this year, the Japanese drugmaker said it expected fiscal 2025 sales of the drug to hit 50 billion yen ($327.3 million).