FDA Review Extension and Industry Impact

Bayer announced on Friday that the FDA requires additional time to review the new drug application for elinzanetant, pushing the Prescription Drug User Fee Act (PDUFA) date to October 26, 2025. The German pharmaceutical company emphasized that the FDA did not raise concerns regarding the general approvability of the drug.

This delay is part of a broader trend of FDA review extensions in recent months. Analysts at Barclays described the postponement as a "small negative" for Bayer, which has projected peak sales for elinzanetant at 1 billion euros ($1.2 billion). The company is expected to provide more details during its second-quarter earnings presentation on August 6.

Elinzanetant: A Non-Hormonal Alternative for Menopausal Symptoms

Elinzanetant, which will be marketed under the brand name Lynkuet, is positioned as a hormone-free treatment for moderate to severe hot flashes associated with menopause. The drug is a dual-action neurokinin antagonist, targeting both NK-3 and NK-1 receptors involved in body temperature regulation.

Bayer's application is supported by data from three large late-stage studies known as OASIS 1, 2, and 3. These trials demonstrated that elinzanetant reduced both the severity and frequency of vasomotor symptoms in treated women compared to those receiving a placebo.

If approved, elinzanetant would join Astellas Pharma's Veozah as the second non-hormonal option for menopausal women in the U.S. market. However, Bayer's drug may have a competitive edge, as Veozah has struggled commercially and recently received a black box warning for potential liver damage – a side effect not reported in elinzanetant's clinical trials.

Global Regulatory Landscape and Market Outlook

While the FDA's decision is pending, elinzanetant has already gained approval in other key markets. The United Kingdom and Canada recently cleared the drug for use, with Bayer preparing to launch it under the Lynkuet brand name in these countries.

Christian Rommel, Bayer's global head of research and development, expressed confidence in elinzanetant's potential, stating, "We remain confident about elinzanetant's potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause."

As the pharmaceutical industry awaits the FDA's decision, the delay highlights ongoing challenges faced by both regulators and drug developers in bringing new treatments to market efficiently. The outcome of this review will be closely watched by industry stakeholders and patients alike, potentially shaping the landscape of menopause treatment options in the coming years.