- The Food and Drug Administration has approved Veozah (fezolinetant), a medication to treat menopausal symptoms.
- The drug, produced by Tokyo-based Astellas Pharma, significantly reduces the hot flashes and night sweats that accompany menopause.
- Veozah is considered a major development for menopause treatment because hormone therapy is not feasible for all patients.
The Food and Drug Administration has approved a once-daily pill to deal with uncomfortable hot flashes brought on by menopause.
The new drug, Veozah (fezolinetant), differs from the traditional treatment of increasing the hormones estrogen and progesterone to reduce menopausal 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 for women and affect their quality of life,” Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic, 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.”
Hormone therapy is not feasible 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 go through menopause each year, according to the National Institute on Aging, and it is estimated that about 85% of postmenopausal women will experience 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, as the body slowly produces less of the hormones estrogen and progesterone. The transition to menopause usually lasts about seven years; menopause is reached when there is no menstruation for 12 consecutive months.
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This new drug fills an “unmet need,” said Dr. Lauren Streicher, 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 drug?
The FDA approved Veozah after several studies found it significantly reduced vasomotor symptoms (VMS), the medical term for hot flashes (also called hot flashes) and night sweats due to menopause.
One 45-milligram pill is taken by mouth each day, with or without food, and should be taken at the same time each day. The drug carries an FDA warning about possible liver damage. Women will need to be screened for liver damage or infections before receiving a prescription, and then have a blood test every three months for nine months to monitor safety issues, according to the FDA label.
The most common side effects: abdominal pain, diarrhea, insomnia, back pain, hot flashes and elevated levels of liver enzymes.
The drug may be beneficial for people over 60 because, at that age, starting hormone treatments can be considered risky, Streicher, who was not involved in the study but reviewed its findings, told The Times.
“Another good thing about the clinical trials is that they had a good sample of women — black women, Asian women, Latino women,” she said. “And it worked just as well on black women as it did on white women – that’s huge.”
How much will the new menopause drug cost?
Astellas Pharma, based in Tokyo, Japan, said the drug will cost $550 for a month’s supply. This price is before insurance coverage is included – 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, what will be the biggest issue, I’m sure in my practice and everyone else’s practice, is exactly what the price 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 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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