The National Health Surveillance Agency (Anvisa) granted approval to a new therapeutic approach, non-hormonal in nature, to mitigate the hot flashes and night sweats that accompany menopause. Commercially known as Veoza and developed by Astellas Farma, this drug offers a valuable alternative for women who cannot use hormone replacement therapy, often considered the reference in the treatment of these discomforts. The treatment regimen involves taking one tablet daily.
Gynecologist Nilson Roberto de Melo, president of the Brazilian Climatic Association (SOBRAC), emphasizes that Anvisa’s approval of fezolinetan represents fundamental progress in the area of women’s health. He highlights that the approval meets a considerable demand, often underestimated, that affects thousands of women during menopause, opening up new therapeutic perspectives.
According to the specialist, the newly approved medicine promises to bring significant benefits to patients, relieving not only “hot flashes” and night sweats, which drastically compromise quality of life, but also favoring a more balanced psychological well-being. For the doctor, it is crucial that women’s health at this stage is treated with due seriousness, and this new therapy is an essential step towards ensuring greater comfort and dignity.
Vasomotor symptoms, such as hot flashes and night sweats, are experienced by up to 80% of women aged between 40 and 65 years. The new medication works by restoring balance in the brain center responsible for temperature regulation, the hypothalamus, helping to reduce the incidence and intensity of these uncomfortable episodes.
Before the menopause phase, the body maintains a harmony between estrogens, produced by the ovaries, and neurokinin B (NKB), a substance present in the brain. This stability is essential to regulate the body’s thermal control center. With the arrival of menopause, estrogen levels drop, unbalancing this relationship and triggering hot flashes and sweating.
In Brazil, data reveals that 36.2% of menopausal women (between 40 and 65 years old) face these symptoms at moderate to high levels of intensity, a rate that exceeds the global average of 15.6%. Alarmingly, almost 70% of affected Brazilian women classify these manifestations as severe, indicating a profound impact on sleep quality, productivity and general well-being.
In addition to deteriorating quality of life, the lack of treatment for hot flashes and night sweats can lead to increased risks for cardiovascular health and the development of neurodegenerative diseases, such as dementia.
Gynecologist Thaís Ushikusa, medical director of Astellas Farma Brasil, states that fezolinetant transforms the understanding and management of menopause symptoms. She explains that, traditionally associated with reduced estrogen levels, these symptoms are now addressed by an innovative mechanism of action, focused on the biology of hot flashes.
The director adds that this approach expands treatment options and opens a new period in women’s health care, offering a non-hormonal alternative for those who need it. The approval of fezolinetant was eagerly awaited by both patients and professionals who treat moderate to severe vasomotor symptoms during menopause.
The decision to approve fazolynetant is based on the results of three Phase 3 clinical studies, which involved more than 3,000 participants in Europe, the United States and Canada.
These studies proved the effectiveness and safety of the treatment in the short and long term. Significant improvements were observed in the frequency and intensity of vasomotor symptoms, in addition to improvements in the quality of life and sleep of menopausal women, with results noticeable from the first day of using the medication.