Recently, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom officially approved the marketing of elinzanetant, a non-hormonal drug developed by Bayer, for the treatment of moderate to severe vasomotor symptoms associated with menopause (such as hot flashes and night sweats). This approval is a milestone, and elinzanetant has become the world's first neurokinin-1 and -3 (NK-1,3) dual receptor antagonist approved for this indication.

Menopause is a natural stage in many women's lives, but the symptoms that come with it, such as hot flashes and night sweats, bring a lot of inconvenience to their lives. Traditionally, hormone replacement therapy has been the main treatment, but many women are unable or unwilling to take this treatment due to its potential side effects.

The emergence of elinzanetant brings new hope to these women. The drug effectively relieves menopausal hot flashes by inhibiting overactive KNDy neurons in the hypothalamus (which express NK-1 and NK-3 receptors) and rebalancing the body's temperature regulation center. Elinzanetant is a once-daily oral capsule that provides a new non-hormonal treatment option for women who are unable to accept or unwilling to use hormone replacement therapy.

The approval is based on three Phase III clinical studies (OASIS-1, -2 and -3), which included more than 1,400 women aged 40-65. The results of the trials showed that elinzanetant can significantly reduce the frequency and severity of hot flashes, improve sleep quality, and enhance menopausal-related quality of life. More than 80% of the subjects reduced the frequency of hot flashes by at least 50% within 26 weeks, and the efficacy can last up to 52 weeks. Common adverse reactions include headaches, fatigue, and drowsiness, but these side effects are usually mild, and most patients can relieve them on their own within two weeks.

The approval of elinzanetant not only brings new treatment options to menopausal women in the UK, but also brings hope to women around the world. The UK is the first market in the world where elinzanetant is approved, and Bayer is simultaneously advancing registration applications in the United States, the European Union and other regions. The US FDA has set a target approval date of July 2026. Bayer said it will continue to expand its women's health product portfolio to meet the diverse treatment needs of menopausal women.

Currently, elinzanetant is available through private prescriptions in the UK. In the future, whether it will be included in the reimbursement scope of the UK National Health Service (NHS) will be evaluated and decided by the UK National Institute for Health and Care Excellence (NICE).

https://news.yaozh.com/archive/45777.html