FDA greenlights a new type of drug for menopausal hot flashes

The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause.

Veozah, or fezolinetant, made by Astellas Pharma, is the first approved neurokinin 3 (NK3) antagonist. It blocks receptors in the brain that play a role in the regulation of body temperature. It’s an alternative to traditional hormone replacement therapies to manage hot flashes, which are a common symptom of menopause that can be disruptive if they become severe.

Women at higher risk of stroke, heart attacks or some kinds of cancer are sometimes advised against using hormone replacement therapies because they increase the risk of blood clots and cancers.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Center for Drug Evaluation and Research, in a news release. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Menopause is a normal period in a woman’s life that usually begins in her mid- to late 40s. During menopause, the body produces less estrogen and progesterone. The tapering of these hormones can trigger sleep disruptions, mood swings and hot flashes – periods of sweating, flushing and chills that may last several minutes.

In clinical trials that included more than 3,000 women in the US and Canada, Veozah reduced the number of hot flashes women experienced each week significantly more than a placebo. The studies followed women who took the drug for a year.

“I think at the end of the day, it’s always good that women have more options, so I’m happy to see that there’s been further development in an overlooked field, and that is menopausal medicine. And that for women to have more options is always a good thing,” said Dr. Stephanie Faubion, director of the Mayo Clinic’s Center for Women’s Health.

“Does that mean we’re going to abandon all existing therapies and head to this as the answer for everyone? No. And we still have a lot more to learn about this class of medication, but it’s excellent that we have choices,” said Faubion, who was not involved in Veozah’s development.

For many women, short-term hormone replacement therapy is still going to be the most-effective and least-expensive option for dealing with hot flashes, she said.

Hormone replacement got a bad rap in 2002, after a government-funded health study found that it could raise the risk of cancer and blood clots. Faubion said use of these therapies fell from 40% of post-menopausal women taking them to just 4% to 6% today.

“It’s been orders of magnitude decrease in the use of hormone therapy, and that’s because people are scared of the risks and benefits of hormone therapy, but we’ve since had studies that show that for most healthy women who are under the age of 60 and within 10 years of their last menstrual period, the benefits outweigh the risks,” said Faubion, who is also medical director of the North American Menopause Society.

A December report by the Institute for Clinical and Economic Review, or ICER, rated the clinical evidence supporting the drug as promising but inconclusive that it would provide a net benefit over no pharmacologic treatment at all. The institute concluded that the drug would be considered cost-effective for women who can’t take hormone replacement therapy or who choose not to take it if priced at $2,000 to $2,500 per year.

Astellas announced Friday that the price of the drug before insurance would be $550 a month, or about three times as high as the ICER benchmark.

Veozah comes with a warning about a risk of liver injuries. The FDA says women who are considering taking it should have blood tests to make sure they don’t have any liver damage or infection before starting the medication, and they should be monitored with blood tests every three months for the first nine months to make sure they don’t show signs of liver damage while taking the drug.

The most common side effects reported in the studies were abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated liver enzymes.

CNN’s Meg Tirrell contributed to this report.