- Elinzanetant, a dual neurokinin-targeted therapy, is approved in the UK for menopausal vasomotor symptoms.
- Phase III trials OASIS-1, -2, and -3 showed positive results for elinzanetant's efficacy and safety.
- Elinzanetant is under regulatory review in the US, EU, and other global markets.
- Vasomotor symptoms affect up to 80% of women during menopause, impacting quality of life.
Approval and Treatment
The UK Medicines and Healthcare products Regulatory Agency has approved elinzanetant, branded as Lynkuet™, for treating moderate to severe vasomotor symptoms (VMS) associated with menopause. This marks the first global approval for this dual neurokinin-targeted therapy, which acts as an NK-1 and NK-3 receptor antagonist.
Clinical Trials
The approval is based on positive outcomes from Phase III trials OASIS-1, -2, and -3. These studies demonstrated that elinzanetant significantly reduced the frequency and severity of VMS compared to placebo, with sustained efficacy and a favorable safety profile over 52 weeks. Common side effects included headache, fatigue, and somnolence.
Mechanism of Action
Elinzanetant targets hypothalamic neurons expressing NK-1 and NK-3 receptors, which are involved in thermoregulation. The decline in estrogen during menopause or endocrine therapy for breast cancer leads to hyperactivity of these neurons, causing VMS. The therapy is administered orally once daily.
Global Regulatory Status
Following the UK approval, elinzanetant is under regulatory review in the United States, European Union, and other international markets. The aim is to expand its availability to address the unmet needs of women experiencing menopausal symptoms worldwide.
Impact of Vasomotor Symptoms
Vasomotor symptoms, such as hot flashes, affect up to 80% of women during menopause, significantly impacting their quality of life. These symptoms can persist for over a decade, leading many women to seek medical intervention. Addressing these symptoms is crucial for maintaining health, quality of life, and productivity.
