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Food and Drug Administration on Friday He approved the first non-hormonal drug For the treatment of hot flashes in postmenopausal women, providing a potential treatment for symptoms of upper body temperature and sweating that can disrupt daily life for years.
The drug, which will be marketed as Veozah, is the first to target a nerve cell in the brain that becomes unbalanced as estrogen levels drop. It’s usually prescribed to women in their 50s during the seven-year menopause phase, according to Marcy English, vice president of Astelas Pharma, the drug’s manufacturer.
The agency said the drug relieved moderate to severe symptoms.
Why it matters: There are few harmless antidotes
A periodic high temperature is a common symptom of menopause, which Astelas suggests affects at least 60 percent of women.
“Hot flashes as a result of menopause can be a serious physical burden for a woman and affect her quality of life,” said Dr. Janet Maynard, an official in the Food and Drug Administration’s Center for Drug Evaluation and Research.
It can be prolonged and interfere with basic functions in daily life.
Hormonal therapies, including estrogen and progestin, have been linked to an increased risk of blood clots and strokes for decades, but Another study showed that the risks are much lower In women in their forties and fifties.
BACKGROUND: Symptoms have long been tolerated
Hot flashes are the most common side effect of menopause for which women usually seek treatment, Estellas said.
Complaints of severe hot flashes and other menopause symptoms in the workplace and elsewhere are often ignored.
“It’s a distraction,” said Mrs. English. “It’s uncomfortable. It’s something we’ve kind of worked through in silence.”
In year-long studies, the drug was found to be generally effective and safe, with side effects including stomach pain, diarrhea, and insomnia, according to the Food and Drug Administration.
Because some patients showed signs of liver damage while the drug was being studied, the FDA said patients should have blood tests before starting the drug to test for existing liver problems, and then repeat tests for the first nine months of taking the drug.
“Patients with symptoms related to liver damage — such as nausea, vomiting, or yellowing of the skin and eyes — should contact a physician,” Food and Drug Administration. The statement says.
What’s next: The price of the drug can be steep
The drug will cost $550 for 30 days, Astillas said, not including rebates. The company said it would start a support program to “help patients access their prescribed medications.” The Institute for Clinical and Economic Review advised a lower rate of $2,000 to $2,600 per year.
Ms English said Astellas was ready to get the drug in pharmacies within three weeks of approval.
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