Bayer's Lynkuet Receives FDA Approval for Treating Menopausal Hot Flashes

The U.S. Food and Drug Administration (FDA) has granted approval to Bayer's novel oral therapy, elinzanetant, for the treatment of moderate to severe hot flashes in menopausal women. The drug, to be marketed under the brand name Lynkuet, represents a significant advancement in menopause management as the first FDA-approved therapy that targets both neurokinin 1 and neurokinin 3 receptors to alleviate vasomotor symptoms (VMS).

Clinical Efficacy and Safety Profile

Lynkuet's approval is supported by robust data from Bayer's comprehensive Phase III OASIS development program. The OASIS 1 and OASIS 2 studies demonstrated significant symptom relief, with patients experiencing a 55.9% reduction in VMS after 4 weeks and up to 67% improvement at 12 weeks. These findings were further corroborated by the OASIS 3 study, which provided evidence of Lynkuet's long-term safety and efficacy over a 52-week period.

The drug's safety profile was generally favorable, with the label noting potential risks such as daytime impairments and sleepiness. Importantly, Lynkuet is contraindicated in pregnant women due to the risk of pregnancy loss.

Mechanism of Action and Administration

Lynkuet's unique mechanism of action involves blocking both neurokinin 1 and neurokinin 3 receptors on neurons, effectively interrupting the heat generation process during hot flashes. This dual-receptor targeting approach distinguishes Lynkuet from existing therapies in the market.

The medication is administered as a gel capsule to be taken once daily before sleep, offering a convenient treatment option for menopausal women experiencing moderate to severe hot flashes.

Expanding Treatment Options for Specific Patient Populations

In addition to its primary indication, Bayer has explored Lynkuet's potential benefits in women with HR-positive breast cancer undergoing endocrine therapy. The OASIS 4 study, conducted outside the U.S., showed a significant decrease in VMS at week 4 compared to placebo, with sustained effects through 12 weeks. This data suggests potential applications for Lynkuet in managing treatment-induced hot flashes in cancer patients, though further regulatory steps may be required for this specific indication.

With Lynkuet scheduled to become available in the U.S. market in November, this FDA approval marks a noteworthy advancement in the treatment landscape for menopausal symptoms, offering a new option for millions of women seeking relief from hot flashes.