June 3, 2023

The Food and Drug Administration on Friday approved the first nonhormonal medication to treat hot flashes in menopausal women, offering a potential cure for the symptoms of upper body overheating and sweating that can disrupt daily life for years.

The drug, which will be marketed as Veozah, is the first to target a neuron in the brain that becomes unbalanced as estrogen levels drop. According to Marci English, a vice president of Astellas Pharma, the drug’s maker, it would typically be prescribed to women in their 50s during the menopause phase, which is estimated to last seven years.

The agency said the drug was approved for moderate to severe symptoms.

Periodic overheating is a common symptom of menopause, which Astellas suggests affects at least 60 percent of women.

“Hot flashes due to menopause can be a serious physical strain on women and affect their quality of life,” said Dr. Janet Maynard, an official with the FDA Center for Drug Evaluation and Research.

They can be long-lasting and interfere with basic functions in daily life.

Hormonal treatments, including estrogen and progestin, were associated with increased risks of blood clots and stroke decades ago, but further research has shown that the risks are much lower in women in their 40s and 50s.

Hot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said.

And the complaints of those experiencing severe hot flashes and other menopausal symptoms are often dismissed in the workplace and elsewhere.

“It’s distracting,” Mrs. English said. “It’s uncomfortable. It’s something that we more or less managed to do quietly.

In years of studies, the drug has been found to be effective and generally safe, with side effects including stomach pain, diarrhea and insomnia, according to the FDA

Because signs of liver damage emerged in some patients during the study of the drug, the FDA said patients should have blood tests done before starting the medication to test for existing liver problems and then repeat the tests for the first nine months after taking the drug.

“Patients experiencing symptoms related to liver damage — such as nausea, vomiting, or yellowing of the skin and eyes — should contact a physician,” the FDA statement said.

Astellas said the drug would cost $550 for a 30-day supply, not including discounts. The company said it would launch a support program “to help patients access the medication they were prescribed.” The Institute for Clinical and Economic Review recommended a lower price of $2,000 to $2,600 per year.

Ms English said Astellas was willing to have the medication in pharmacies within three weeks of approval.