Bayer's Lynkuet Receives FDA Approval for Menopausal Hot Flash Treatment

Bayer has secured FDA approval for its novel oral therapy, Lynkuet (elinzanetant), marking a significant advancement in the treatment of moderate to severe hot flashes in menopausal women. The drug, set to be available in the United States this November, represents the first FDA-approved therapy that targets both neurokinin 1 and neurokinin 3 receptors to alleviate vasomotor symptoms (VMS).

Groundbreaking Mechanism of Action

Lynkuet's unique approach involves blocking the neurokinin 1 and neurokinin 3 receptors on neurons, effectively interrupting the mechanism responsible for heat generation during hot flashes. This dual-action pathway is a first in the pharmaceutical landscape for VMS treatment, potentially offering new hope for millions of women experiencing menopausal symptoms.

Compelling Clinical Trial Results

The FDA's decision was supported by robust data from Bayer's comprehensive Phase III OASIS development program. Key findings from the trials include:

• OASIS 1 and OASIS 2: These studies demonstrated significant symptom relief, with VMS reductions of 55.9% and 57.9% after 4 weeks, increasing to 65.2% and 67% at week 12, respectively.

• OASIS 3: This 52-week study affirmed Lynkuet's long-term safety and efficacy, maintaining a favorable safety profile throughout the extended follow-up period.

• OASIS 4: Conducted outside the U.S., this trial focused on women with HR-positive breast cancer undergoing endocrine therapy. Results showed a significant decrease in VMS at week 4 compared to placebo, with sustained effects through 12 weeks.

Administration and Safety Considerations

Lynkuet is administered as a gel capsule to be taken once daily before sleep. While the drug has shown promising results, the label does highlight potential risks, including daytime impairments and sleepiness. Additionally, Lynkuet is contraindicated for pregnant women due to the risk of pregnancy loss.

As Bayer prepares for the November launch of Lynkuet in the U.S. market, this approval represents a noteworthy advancement in menopausal symptom management, offering a novel treatment option for women seeking relief from hot flashes.