In a groundbreaking development, medical experts anticipate a revolution in menopause treatments with the introduction of a drug that directly targets the brain to alleviate hot flushes. Following the approval of the first non-hormonal menopause drug by the United States, manufactured by Astellas Pharma, doctors believe this treatment could be transformative for the countless women in the UK who are unsuitable for hormone replacement therapy (HRT). The US granted a license to the drug fezolinetant on May 12, and regulatory approval for its use in the UK is anticipated by the end of this year.
Professor Waljit Dhillo, an esteemed endocrinologist at Imperial College London who led a pioneering trial in 2017 that paved the way for the drug’s development, expressed his optimism, stating, “This is going to be a blockbuster drug. It’s like a switch. Within a day or two, the flushes go away. It’s unbelievable how well these drugs work. It’s going to be completely game-changing for a lot of women.”
Fezolinetant, currently under assessment by the European Medicines Agency (EMA), functions by blocking a brain protein called neurokinin-3, which plays a crucial role in regulating body temperature in menopausal women.
A large clinical trial published in March assessed the efficacy of fezolinetant over a 12-week period. The results revealed that it reduced the frequency of hot flushes by approximately 60% in women experiencing moderate or severe symptoms, compared to a 45% reduction observed in the placebo group. Women also reported that the drug mitigated the severity of hot flushes and improved the quality of their sleep.
Professor Richard Anderson, co-director of the Centre for Reproductive Health at the University of Edinburgh, commented on the remarkable speed and effectiveness of these drugs, saying, “What’s really amazing about these drugs is how quickly they work and how big an effect they have. Typically, estrogen takes several weeks to have an effect. With these, women are reporting effects from the first tablet.”
Approximately 70% of women undergoing menopause experience hot flushes, with 10-20% describing them as “near intolerable,” significantly impacting their daily lives, exercise routines, and sleep. Hot flushes often manifest as a sudden wave of heat over the upper body, resulting in flushed and sweaty faces, necks, and chests. Some individuals may also experience lightheadedness or a racing heart.
In England alone, nearly 2 million women were prescribed at least one HRT medication last year. However, HRT is unsuitable for certain patients with a history of breast or ovarian cancer, blood clots, or untreated high blood pressure. Additionally, some women experience side effects or prefer non-hormonal alternatives.
Professor Annice Mukherjee, a consultant endocrinologist and visiting professor at the University of Coventry, emphasized the importance of providing effective alternatives for women who cannot take HRT, stating, “If you can’t take HRT, there isn’t much in the way of really effective options. Women need options.”
Fezolinetant acts directly on the temperature control pathway in the brain and does not replace the steep decline of estrogen that occurs during menopause. Consequently, it does not address the broader range of symptoms that some women experience, such as fatigue, muscle and bone weakness, vaginal atrophy, and mood swings. The EMA expects to receive an application from Astellas and make a decision toward the end of 2023, followed by a decision in the UK a few months later.
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