- The Food and Drug Administration has approved Veozah (fezolinetant), a drug to treat symptoms of menopause.
- The drug, manufactured by Tokyo-headquartered Astellas Pharma, was found to significantly reduce hot flashes and night sweats that accompany menopause.
- Veozah is considered an important development for menopause treatment because hormone therapy is not viable for all patients.
The Food and Drug Administration has approved a once-a-day pill to manage uncomfortable hot flashes caused by menopause.
The new drug, Veozah (fezolinetant), differs from the traditional treatment of increasing the hormones estrogen and progestin to reduce menopause symptoms, which include sweating, flushing and chills. Veozah, developed by Astellas Pharma, 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 affect their quality of life,”[ads1]; Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urology and Reproductive Medicine, said 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 is not viable for all patients, especially those who have been treated for breast cancer or have a history of stroke, blood clots, heart attacks and other health conditions.
When does menopause occur 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 is estimated that approximately 85% of postmenopausal women have experienced symptoms during their lifetime. Bouts of sweating, flushing and chills can last for several minutes, the FDA said.
Menopause usually occurs between the ages of 45 and 55 when the body slowly produces less of the hormones estrogen and progesterone. The menopausal transition usually lasts around seven years; menopause is reached when there has been no menstruation for 12 consecutive months.
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This new drug fills 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 have been waiting for a long time.
What do we know about the newly approved menopause?
The FDA approved Veozah after several studies found it reduced vasomotor symptoms (VMS), the medical term for hot flashes (also called hot flashes) and night sweats due to menopause.
A 45 milligram pill is taken orally each day, with or without food, and should be taken at the same time each day. The drug has an FDA warning about potential liver damage. Women must be screened for liver damage or infection before getting a prescription, then have a blood test every three months for nine months to monitor for safety concerns, according to the FDA label.
The most common side effects: stomach pain, diarrhea, insomnia, back pain, hot flashes and elevated levels of liver enzymes.
The drug may be beneficial for those over 60, because at that age starting hormonal treatments can be considered risky, Streicher, who was not involved in the study but reviewed the findings, told The Times.
“The other thing that’s nice about the clinical trials is that 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 it did in white women — that’s huge.”
How much will the new menopause cost?
Tokyo, Japan-based Astellas Pharma said the drug will cost $550 for a month’s supply. This price is before insurance coverage is taken into account – and before other discounts usually negotiated by insurance companies and pharmacy 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, what’s going to be the biggest issue I’m sure in my practice and everybody else’s practice is just what the cost 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, but most of your patients can’t access it or can’t afford it.”
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Contributors: Adrianna Rodriguez, USA Today, Associated Press.
Follow Mike Snider on Twitter: @mikesnider.
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