- The Food and Drug Administration has approved Veozah (fezolinetant), a drug to treat symptoms of menopause.
- The drug, produced by Tokyo-headquartered Astellas Pharma, was found to significantly reduce hot flashes and night sweats that accompany menopause.
- Veozah is considered a major development for menopause treatment because hormonal therapy is not viable for all patients.
The Food and Drug Administration has approved a once-a-day pill for dealing with uncomfortable hot flashes brought on by menopause.
The new drug, Veozah (fezolinetant), differs from the traditional treatment of boosting the hormones estrogen and progestin to reduce menopause symptoms, which include sweating, flushing and chills. Developed by Astellas Pharma, Veozah blocks a chemical in the brain called neurokinin B (NKB), which regulates body temperature.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in a statement. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
Hormonal therapy isn’t viable for all patients, especially those who have been treated for breast cancer or have a history of stroke, blood clots, heart attack and other health conditions.
When does menopause happen and why does it occur?
More than 1 million women in the United States experience menopause each year, according to the National Institute on Aging, and it’s estimated about 85% of postmenopausal women have experienced symptoms in their lifetime. Bouts of sweats, flushing and chills can last for several minutes, the FDA said.
Menopause usually occurs between the ages of 45 and 55 as the body slowly produces less of the hormones estrogen and progesterone. The menopausal transition typically lasts about seven years; menopause is reached when there’s been no menstrual period for 12 consecutive months.
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This new drug addresses an “unmet need,” Dr. Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University and medical director of the Northwestern Medicine Center for Menopause, told The New York Times. “When you think about the impact of vasomotor symptoms on work, on cognitive function, on sleep, on quality of life – the availability of another option is exciting,” she said. “This is something we’ve been anticipating for a long time.”
What do we know about the newly approved menopause drug?
The FDA approved Veozah after several studies found it significantly reduced vasomotor symptoms (VMS), the medical term for medical term for hot flashes (also called hot flushes) and night sweats due to menopause.
One 45 milligram pill is taken orally each day, with or without food, and should be taken at the same time each day. The drug carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.
The most common side effects: abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated levels of liver enzymes.
The drug may be beneficial to those over 60 because at that age, starting hormonal treatments can be considered risky, said Streicher, who was not involved with the study but reviewed its findings, told The Times.
“The other thing that’s nice about the clinical trials is they had a good cross-section of women – Black women, Asian women, Latina women,” she said. “And it worked just as well in Black women as in white women – that’s huge.”
How much will the new menopause drug cost?
The Tokyo, Japan-based Astellas Pharma said the drug will cost $550 for a one-month supply. That price is before insurance coverage is factored in – and before other discounts typically negotiated by insurers and pharmacy benefit managers.
The pills could be available in pharmacies within weeks, Marci English, vice president and head of BioPharma Development at Astellas, the drug’s maker, told NBC News.
“Unfortunately, the thing that’s going to be the biggest issue I’m sure in my practice and everybody else’s practice is just what the pricing of the drug is,” Dr. Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health, told NBC News. “It’s very frustrating to have an exciting drug that works, yet most of your patients can’t get access to it or can’t afford it.”
More coverage from USA TODAY
Contributing: Adrianna Rodriguez, USA Today, The Associated Press.
Follow Mike Snider on Twitter: @mikesnider.
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