FDA Delays Approval Decision for Bayer's Menopause Therapy Elinzanetant

The U.S. Food and Drug Administration (FDA) has extended its review of Bayer's non-hormonal therapy for menopausal hot flashes, elinzanetant, by three months. This delay comes as regulators in Canada and the United Kingdom have already cleared the drug for use under the brand name Lynkuet.

FDA Review Extension

Bayer announced on Friday that the FDA requires additional time to review the company's application for elinzanetant. The agency did not raise concerns about the "general approvability" of the drug, according to the company's statement. Christian Rommel, Bayer's global head of research and development, expressed confidence in elinzanetant's potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause.

The pharmaceutical giant submitted elinzanetant for FDA review in August 2024, based on three large late-stage studies known as OASIS 1, 2, and 3. These trials demonstrated that the drug reduced both the severity and frequency of vasomotor symptoms, commonly known as hot flashes, compared to placebo.

Competitive Landscape and Market Implications

If approved, elinzanetant would join Astellas Pharma's Veozah as a non-hormonal option for menopausal women in the United States. Both drugs target the neurokinin 3 receptor, which is involved in regulating body temperature. Elinzanetant also targets the neurokinin 1 receptor, potentially giving it a competitive edge.

Bayer's drug may have an advantage over Veozah, which has struggled commercially and recently received a black box warning from the FDA for the risk of liver injury. In contrast, Bayer has not reported similar side effects from elinzanetant's clinical trials.

Broader Industry Context

The FDA's delay in reviewing elinzanetant is not an isolated incident. Recent analysis by RBC Capital Markets has identified "some potentially concerning signals of greater missed target dates" for FDA approvals. While it's unclear whether these delays stem from a more methodical approach, resource limitations at the agency, or issues with drug company submissions, the trend suggests an increased risk of delays for drugmakers with decision deadlines in the latter half of 2025.

As the pharmaceutical industry continues to navigate these regulatory challenges, companies like Bayer remain committed to bringing new treatments to market. "We are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval," Rommel stated, emphasizing the company's dedication to addressing unmet medical needs in women's health.