FDA approves first-of-its-kind drug for treating hot flashes

CLOCK: Breakthrough drug treatment for hot flashes approved

Women have suffered for centuries from hot flashes, one of the most common symptoms of menopause, without many treatment options.

Now, the U.S. Food and Drug Administration has approved a first-of-its-kind drug, fezolinetant, sold under the brand name Veozah, for the treatment of moderate to severe hot flashes during menopause.

The drug, a pill taken once a day, is hormone-free, making it promising for women who can’t take hormone treatment due to other underlying health issues, such as a previous history of strokes, heart attacks, or blood clots of blood.

According to the FDA, the drug works by targeting the temperature control center of the brain to decrease both the frequency and intensity of hot flashes in women.

Prior to the FDA approval of fezolinetant, the main treatment options for menopause-related hot flashes were hormone replacement therapy (HRT) and certain types of antidepressants.

“Hot flashes due to menopause can place a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, at the Center for Drug Evaluation and Research, said a statement. “The introduction of a new molecule for the treatment of moderate to severe menopausal hot flashes will provide another safe and effective treatment option for women.”

Menopause is the point 12 months after a woman’s last and final period. The transition to menopause, also known as perimenopause, can take place over the course of several years, which is also when women may experience symptoms such as hot flashes, according to the National Institutes of Health.

Symptoms of menopause include everything from well-known hot flashes and night sweats to lesser-known and much-discussed symptoms like anxiety, vaginal dryness, painful intercourse, decreased sexual function, insomnia, and joint pain. The age at which a woman enters menopause can be influenced by factors such as genetics, autoimmune conditions, trauma to the ovaries, and toxic exposures such as chemotherapy and radiation.

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Most women experience the menopausal transition between the ages of 45 and 55, according to the NIH.

About 5 percent of women naturally go through early menopause between the ages of 40 and 45, according to the U.S. Bureau of Women’s Health.

Marci English, vice president and head of biopharmaceutical development at Astellas Pharma, which makes Veozah, said it was a priority for the company to offer a non-hormonal therapy to help women as they could experience several years of symptoms.

“One part when we talk about menopause I think is so overlooked that the menopausal transition takes seven years on average. If we look at women in general, 60 to 80 percent of women will experience hot flashes during the menopausal transition,” she said. told English to ABC. News. “We also know that some women, even after menopause in that postmenopausal period, can experience hot flashes for up to 10 years. It can actually ebb and flow, and it can last a long time.”

She continued, “I think what’s really important for people to understand is this is a non-hormonal therapy, it’s a first-class therapy, and this offers choice for women.”

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Dr. Jessica Shepherd, a board-certified OBGYN and chief medical officer for Verywell Health, told ABC News she thinks the FDA’s approval of fezolinetant could be “game-changing” in the menopause landscape.

In clinical trials, researchers found that fezolinetant reduced hot flashes by more than 50% in most of the women studied.

Patients taking Veozah will need to have routine blood tests every three months for the first nine months of treatment, and those with severe liver and kidney damage should not take the drug.

The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, liver damage and hot flashes, according to the FDA.

Astellas Pharma tells ABC News the drug should be available in pharmacies within three weeks.

“Prescription drug plans will make their own coverage decisions, and we expect coverage to increase throughout the year,” a company spokesperson said on Friday. “We expect VEOZAH to achieve widespread coverage over time. All co-pays vary by plan and benefit design; however, average commercial co-pays in 2022 were $37 for the preferred brand tier and $ 67 for non-preferred brand level”.

Amanda Kravitz, MD, is a pediatrics physician in residence and a member of the ABC News Medical Unit.