Overview
- The FDA cleared Lynkuet (elinzanetant) for moderate to severe vasomotor symptoms, with Bayer saying U.S. availability is expected in November.
- Elinzanetant blocks NK1 and NK3 receptors in the brain’s thermoregulation pathway, reducing hot flashes and night sweats without estrogen.
- Phase 3 trials showed rapid, significant reductions in symptom frequency and severity within weeks, with benefits maintained through 52 weeks.
- Common side effects included drowsiness, fatigue and headaches, and the label warns about elevated liver enzymes, seizure risk, potential pregnancy loss and avoiding grapefruit.
- Bayer listed a wholesale price of about $625 for 30 days and said eligible patients could pay as little as $25 through its access program; the drug is already approved in the UK, Australia, Canada and Switzerland.