FDA Approves New Drug to Treat Hot Flashes

Food and Drug Administration on Friday approved the first non-hormonal drug A product for the treatment of hot flashes in menopausal women, it offers a potential remedy for the symptoms of upper body overheating and sweating that can disrupt daily life for many years.

The drug, which will be marketed as Veozah, is the first to target neurons in the brain that are out of balance as estrogen levels drop. The drug is usually prescribed to women in their 50s who are going through menopause, which is estimated to last seven years, said Marci English, vice president of the drug’s maker, Astellas Pharma.

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

Periodic hot flashes are a common symptom of menopause, and Astellas suggests that at least 60% of women suffer from this condition.

“Hot flashes due to menopause can be a significant physical burden for women and affect their quality of life,” said Dr. Janet Maynard, staff member of the FDA’s Center for Drug Evaluation and Research.

Symptoms can be long-lasting and interfere with basic functions of daily living.

Hormone therapy, including estrogen and progestin, was associated with increased risk of blood clots and stroke decades ago, but additional research shows that the risk is much lower in women in their 40s and 50s. I was.

According to Astellas Pharma, hot flashes are the most common side effect of menopause that women need treatment for.

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

“It’s distracting,” said Mr. English. “It’s distasteful. It’s something we managed to deal with in silence.”

A year-long study found the drug to be effective and generally safe, but had side effects such as stomach pain, diarrhea and insomnia, according to the FDA.

Because some patients had signs of liver damage during the study of this drug, the FDA advised that patients should have blood tests to check for pre-existing liver problems before starting the drug, and then the drug for the first time after taking the drug. He said the test would need to be repeated for nine months.

“Patients experiencing symptoms associated with liver damage, such as nausea, vomiting, and yellowing of the skin and eyes, should consult a physician,” the FDA said. the statement says.

Astellas said the drug will cost $550 (not including rebates) for 30 days. The company said it will launch a support program “to help patients access their prescribed medications.” The Institute for Clinical and Economy Review recommended low prices, from $2,000 a year to he $2,600.

English said Astellas is ready to put the drug in pharmacies within three weeks of approval.

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