HQ Team
May 14, 2023: Astellas Pharma, a Japanese drugmaker, announced that the FDA has approved its oral drug Veozah for the treatment of hot flushes in menopausal women.
Menopause occurs a year after a woman’s last period. During the time leading up to that point, women may experience changes in their monthly cycles and have hot flashes and other symptoms.
The aging process is called the menopausal transition or perimenopause. The menopausal transition often begins between ages 45 and 55.
Severe vasomotor symptoms, such as hot flashes and night sweats due to menopause, drive the patients to seek treatment.
In the US, about 60% to 80% of women experience these symptoms during or after the menopausal transition. These can have a disruptive impact on women’s daily activities and overall quality of life.
Menopausal transition
“Today’s approval of fezolinetant is a significant and, I believe, long-awaited milestone for individuals in the US who experience moderate to severe vasomotor symptoms during the menopausal transition,” said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology.
“This therapy is based on our understanding of the biology behind hot flashes…patients will have the option to choose this nonhormonal treatment.”
Before menopause, there is a balance between hormones made by a woman’s ovaries and neurokinin B (NKB), a brain chemical.
This balance regulates the body’s temperature control center located in a specific area of the brain. As the body goes through menopause, estrogens decline and this balance are disrupted.
The imbalance can lead to hot flushes and night sweats. Veozha helps to restore balance by blocking NKB in the temperature control center to reduce the number and intensity of hot flashes.
‘Root cause’
“Veozah uses a novel mechanism of action to target the root cause of VMS (vasomotor symptoms) due to menopause,” said Marci English, Head of BioPharma Development of Astellas.
The approval comes after phase III clinical trials that collectively enrolled over 3,000 individuals across the US, Canada, and Europe, according to a company statement.
The trials were double-blinded, placebo-controlled for the first 12 weeks, followed by a 40-week treatment extension period. Women were enrolled at more than 180 sites within the US, Canada, and Europe.
“FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health,” said President and CEO, Naoki Okamura.
