Elinzanetant

Drug approval delays have become more common since the FDA lost 19% of its workforce in April due to federally mandated budget cuts. After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment, elinzanetant.On Friday, the German company said in a release that the FDA needed additional time to review its new drug application for elinzanetant, extending the Prescription Drug User Fee Act (PDUFA) review period by up to 90 days.The FDA was expected to make its decision by Saturday on the application, which was filed in August 2024. The new PDUFA date is Oct. 26.Bayer added that the FDA did not “raise any concern regarding the general approvability” of elinzanetant. Earlier this month, regulators in the U.K. endorsed the treatment, which is known commercially as Lynkuet. Canada followed suit last week with a thumbs-up, while a review is ongoing by the European Union.“We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,” Yesmean Wahdan, M.D., Bayer’s head of medical affairs in North America, said in a statement. “We continue to work with the FDA to make this treatment available.”Analysts at Barclays wrote that the delay was a “small negative” for Bayer, which has tabbed peak sales for the treatment at 1 billion euros ($1.2 billion). The company will likely add more details during its second-quarter earnings presentation on Aug. 6.Over the past four months, the FDA has delayed its review of several drugs, but most decisions have still arrived relatively quickly. In May, the agency approved GSK’s Nucala for COPD less than two weeks after its original PDUFA date.In July, the FDA signed off on KalVista’s rare disease drug Ekertly three weeks after its original PDUFA date. And in April and May, it took an extra six weeks to convert Novavax’s COVID-19 vaccine from accelerated to full approval. In May, the FDA took an extra month to reject a rare-disease drug from Stealth BioTherapeutics, though that application has been through a series of regulatory challenges since the Massachusetts company first presented data in 2019.Last week, the FDA also delayed a decision on GSK’s multiple myeloma drug Blenrep by 90 days, which was voted down as an agent in two separate combinations by an FDA advisory committee earlier this month.As for Bayer, it is hoping to join Astellas as the second company with a hormone-free treatment for patients with moderate to severe hot flashes that accompany menopause. While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for the indication, Lynkuet is the first dual-action neurokinin in the indication, targeting the NK-3 and NK-1 receptors. Astellas reported 2024 fiscal year sales of Veozah at 33.8 billion yen ($230 million), which came up short of its expectations. Astellas has projected fiscal 2025 sales at 50 billion yen ($340 million). The company's peak sales projection for the treatment, which carries a black box warning for potential liver damage, is $3.6 billion.Despite being from the same treatment class, Lynkuet has shown scant evidence of the side effects in three phase 3 trials.

The FDA has extended its review of elinzanetant, Bayer's proposed hormone-free option to treat vasomotor symptoms (VMS) associated with menopause, delaying a decision on the drug by up to three months. The move comes as Bayer begins to make inroads outside the US, with recent approvals of the dual NK-1,3 receptor antagonist in the UK and Canada under the brand name Lynkuet.Bayer said the FDA has determined it needs more time to conduct a full review of the submission, including information provided to support the application, adding the agency did not cite any issues with the overall approvability of elinzanetant."We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval," said Yesmean Wahdan, head of medical affairs for Bayer's North American pharmaceutical unit. "We continue to work with the FDA to make this treatment available."The therapy is being positioned as a potential rival to Astellas' NK-3 receptor antagonist fezolinetant, cleared in 2023 by the FDA as Veozah and in Europe as Veoza. Expectations were high for the Japanese drugmaker's VMS treatment, but it underperformed at launch and a liver safety signal has hampered sales (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).The elinzanetant filing includes results from the Phase III OASIS 1 and 2 studies, which were published in JAMA last year and showed significant reductions in VMS frequency and severity over 12 weeks versus placebo. Additionally, over 80% of treated participants achieved a reduction in their VMS frequency of at least half by week 26.In the Phase III OASIS 3 long-term study, women taking elinzanetant demonstrated a sustained significant reduction in the frequency of moderate-to-severe VMS compared to placebo, with no signs of liver toxicity.