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Tuesday, June 25, 2024

New Drug for Hot Flashes Receives FDA Approval

Hot flashes are a common symptom of menopause, and for years they may interfere with a woman’s everyday life. On Friday, the Food and Drug Administration authorised the first nonhormonal medicine to treat hot flashes.

Veozah is the first medicine of its kind to specifically target an imbalanced cell in the brain caused by declining oestrogen levels. According to Marci English, a vice president of Astellas Pharma, the drug would normally be administered for women in their 50s throughout the menopausal period projected to last seven years.

The FDA approved the medication for use in treating moderate to severe symptoms.

According to Astellas, at least 60% of menopausal women have periods of increased body temperature.

They may linger for a long time and make it hard to do even the most fundamental things.

Hormone therapies, such as oestrogen and progestin, were formerly thought to increase the risk of blood clots and strokes in women, but new research shows that this risk is much reduced for women in their forties and fifties.

According to Astellas, women seek medication for menopausal symptoms most often for relief from hot flashes.

People who suffer from severe hot flashes and other menopausal symptoms sometimes have their concerns disregarded by society.

A. “It’s distracting,” Ms. English said. “It’s not pleasant. It’s something we dealt with in relative obscurity.”

According to the F.D.A., the medicine was determined to be effective and usually safe throughout the course of a year-long study, with some patients experiencing adverse effects including stomach discomfort, diarrhoea, and sleeplessness.

Some individuals showed evidence of liver damage during the medicine’s clinical trials, so the Food and medicine Administration mandated that patients have blood work done before beginning the prescription and again within the first nine months of taking the treatment to rule out any preexisting liver issues.

The F.D.A. advises patients who have symptoms including nausea, vomiting, or yellowing of the skin and eyes to see a doctor.

Astellas estimated that the price of a 30-day supply of the medicine would be $550. The business said it will launch a service “to help patients access the medication they were prescribed.” A discount of $2,000 to $2,600 year was suggested by the Institute for Clinical and Economic Review.

After approval, Ms. English said Astellas might have the drug in stores within three weeks.

Jonathan James
Jonathan James
I serve as a Senior Executive Journalist of The National Era
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