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Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.But demand for treatments still far outpaces the science, as persistent structural barriers confound the womens health space.People have taken up the charge and are trying to make an impact in a specific area, said Kim Dalla Torre, an EY Global and Americas Health leader.When it comes to research, womens health has been historically underfunded. Even today, only an estimated 6% of private healthcare funding goes toward womens health, which hinders innovation, according to the World Economic Forum. Women are still underrepresented in clinical research, and doctors are hamstrung by a limited evidence base to guide treatment decisions, Dalla Torre said.A mix of companies has stepped in to fill the gap. While some mainstream healthcare organizations have expanded menopause-specific care options, theres also been a proliferation of smaller companies moving into the space, selling unproven supplements and products that make up the majority of spending in the menopause market.A BMJ article, for example, recently raised concerns about the rise in costly hormone panel testing, which is considered unnecessary by many medical societies, including the American College of Obstetricians and Gynecologists. The tests cost hundreds of dollars but are of limited clinical use because theres no defined window for hormone therapy. Despite this, theyre being used to justify custom hormone regimens that are not tested for efficacy or safety.The studys authors said its a symptom of a larger problem in the commercialization of womens health, and a push away from evidence-based practice. In the absence of R&D investments from the pharma industry, it could also remain a major challenge in the field going forward.Wheres pharma at?Drug development for menopause has been an uphill battle for many drug companies, in part, because of the heterogeneity of symptoms. The estimated 6,000 women a day who reach menopause experience it differently. Some have debilitating, vasomotor symptoms such as hot flashes and night sweats, while for others its brain fog and sleep disturbances.Theres not one condition to go after that a company can put their dollars behind to say this is where Im going to be able to get ROI in womens health ... because [theres] not one drug that is going to solve the problem,Dalla Torre said.Hormone replacement therapy remains one of the main treatments doctors prescribe to manage symptoms, and its risen again after falling out of favor. In the 1990s, HRT was widely lauded as a means to solve many of the problems associated with menopause. That changed rapidly in 2002 when researchers halted a large study, the Womens Health Initiative, amid concerns that HRT increased the risk of serious conditions like breast cancer, heart disease and stroke.But a new analysis of those findings painted a more nuanced picture of HRT, including an understanding that the benefits and risks of treatment are linked to timing.I would love to see biotech companies focus on the space. Once that starts happening, then bigger drug companies can take on the charge and keep expanding it.“Kim Dalla TorreEY Global and Americas Health leaderSome drug developers are also plugging away in the space. Most recently, Bayer gained approval in October for a new drug to treat hot flashes. The NK1 and NK3-targeting treatment Lynkuet will now compete with Astellas Veozah, an NK3-targeting drug that became available in 2023.Bayer estimates Lynkuet could see sales of more than $1 billion annually. Veozah, which recently received an FDA safety warning for rare but serious liver complications, has seen slower-than-expected sales and faced reimbursement complications. More options could be on the way, such as AbCelleras phase 2 NK3R receptor targeting drug.Hot flashes, however, are an easier target for drug developers because they are an indication with more clearly measurable outcomes in the clinic, Dalla Torre said.In other areas, women will need a more individualized approach.If we could think about women's health the way we think about CAR-T, like personalized medicine, and tailor the solution to the person for their particular needs and their symptoms, we could get a lot further, Dalla Torre said.The field, she said, needs to get better at connecting the dots between interrelated conditions that disproportionately affect women, such as autoimmune diseases and Alzheimers, and then study them more closely to find solutions.In the meantime, women are doing what they can to manage menopause symptoms and find their own answers.Women are looking at real outcomes, and they're reading the blogs, they're talking to their friends and their family, Dalla Torre said. They're acting on anecdotal evidence, because, once again, the research isn't there.To give them better options means gathering more evidence, which requires fewer barriers to clinical trial participation, she said. Trials need to be more convenient for women, who often have little free time due to work and caretaking responsibilities for their children and elderly parents.More also needs to be done to raise womens awareness that menopausal symptoms shouldnt be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms dont reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.I would love to see some of our biotech companies focus on the space. Once that starts happening, then the bigger drug companies can take on the charge and keep expanding it to make more of an impact globally, she said. '

Astellas raised its full-year fiscal 2025 revenue forecast by 10% to 2.1 trillion yen, thanks to the strong performance of Padcev and Vyloy.\n Astellas surpassed market expectations in its third-quarter fiscal year 2025 results, as first-in-class cancer drug Vyloy defied a trial setback to deliver quadrupled sales.As the first CLDN18.2 agent to reach the market, Vyloy saw sales swell (PDF) 426% to 19.5 billion Japanese yen ($125 million) during the last three months of calendar year 2025, which marked Astellas’ Q3.In a Wednesday note, Jefferies analysts said they were “impressed by the rapid rise in demand” for the stomach cancer treatment.The strong performance from Vyloy helped Astellas beat analysts’ expectations for total third-quarter sales by 8%, according to Jefferies.Vyloy’s commercial surge comes after Astellas reported a midstage trial failure for the antibody in pancreatic cancer in October. At that time, Astellas said the impact of the trial setback on its financial results for the year was expected to be minor.Moving into the earnings report, Astellas booked a loss of 12.8 billion yen ($82 million) in Q3, tied to the discontinuation of the pancreatic cancer program. Also in pancreatic cancer, Astellas terminated ASP4396, a phase 1 KRAS G12D program, to focus on setidegrasib (ASP3082), another KRAS G12D protein degrader. The difference between the two drugs lies in their E3 ligase design. The prioritization decision was made because ASP4396’s data have yet to top its counterpart’s, despite being later in development, Astellas’ R&D chief Tadaaki Taniguchi said on a Feb. 4 earnings call.A combination of setidegrasib and chemo recently posted a 58.3% objective response rate among 12 patients in first-line pancreatic cancer. Based on the results, Astellas plans to launch a phase 3 study in the indication by March, and it’s also planning registrational studies in non-small cell lung cancer.Astellas would like to accelerate the development of setidegrasib in pancreatic cancer, Taniguchi said, noting that its competitor, Revolution Medicines, has not started a first-line pivotal study.Last year’s clinical setback apparently didn’t dampen enthusiasm around the use of Vyloy in the closing months of 2025. During an investor call Wednesday, Astellas CFO Atsushi Kitamura attributed the drug’s commercial progress to “high Claudin 18 testing rates and lower-than-expected discontinuation rates.”“By focusing on the prevention of nausea and vomiting, particularly in the initial cycle, we believe we can reduce discontinuation and enhance treatment continuation rate,” he said, according to a call transcript provided by Astellas.Astellas is now testing Vyloy in combination with Merck & Co.’s Keytruda and chemotherapy in the phase 3 Lucerna trial in first-line stomach cancer. Enrolled patients have CLDN18.2-high, PD-L1-positive tumors. The company expects an interim readout in its fiscal year 2027 or later.Besides Vyloy, Pfizer-partnered Padcev contributed about a third of Astellas’ overall Q3 sales growth. Sales of the star antibody-drug conjugate jumped 45% during the quarter, reaching 60.1 billion yen ($383 million).In November, the FDA handed down a groundbreaking approval for a combination of Padcev and Keytruda as the first perioperative treatment for patients with muscle-invasive bladder cancer (MIBC) who can’t receive cisplatin-based chemotherapy. The indication was approved just a month after the FDA accepted Astellas and Pfizer’s application.On a winning streak, the Padcev-Keytruda perioperative regimen was also said to have extended the lives of MIBC patients who are cisplatin-eligible in the phase 3 Keynote-B15 (EV-304) trial.Doctors have already started using Padcev in perioperative MIBC, Claus Zieler, Astellas’ chief commercial and medical affairs officer, said during the Feb. 4 investor call. But he cautioned that, based on Astellas’ experience with past Padcev indications, there will be “a very sharp plateau” after “a very fast uptake” in the first six months of rollout as the company tries to penetrate the new patient population completely. Thanks to the strong performance of Padcev and Vyloy, Astellas raised its full-year fiscal 2025 revenue forecast by 10% to 2.1 trillion yen. The company collected 1.6 trillion in the nine months that ended in December.Padcev and Vyloy are two of Astellas’ five strategic brands, which together are nearing 500 billion yen sales on a full-year basis, Kitamura said.Astellas is pinning its future on the strategic brands—which also include menopause therapy Veozah, eye med Izervay and leukemia drug Xospata—as its Pfizer-partnered prostate cancer juggernaut Xtandi nears a 2027 U.S. patent cliff. In Q3, Veozah and Izervay expanded sales by 28% and 33%, respectively, while Xospata was relatively flat.In the pipeline, Astellas has highlighted four “primary focus flagship programs.” Besides setidegrasib, the group also includes ASP2138, a CLDN18.2xCD3 bispecific; AT845, a gene therapy designed for Pompe disease; and ASP7317, a cell therapy for geographic atrophy.In Q3, Astellas reports that it achieved proof of concept for ASP2138 in first-line stomach cancer and is now preparing to launch a phase 3 trial.“This is very good news because it means that Astellas now has a healthy-looking late-stage R&D pipeline,” the Jefferies analysts said. “This, matched with its fast-growing portfolio of on-market products, is likely to broaden the appeal of Astellas\' stock to a broader group of investors.”