The Food and Drug Administration on Friday approved fezolinetant, or Veozah, to treat hot flashes for women in menopause. The non-hormonal drug treatment is the first of its class and represents an option for women who cannot take hormones.
Menopause occurs when women do not get a period for 12 consecutive months, usually beginning between ages 45 and 55. Hot flashes are the most common menopausal symptom and can interfere with quality of life. Of those in menopause, more than 80% of them suffer from hot flashes.
More women are entering menopause as well, as people are living longer and the substantial Gen X generation ages into menopause.
“It’s great that this is going to market,” said Dr. Beth Prairie, an OBGYN and preventive medicine physician at Allegheny Health Network Midlife Women’s Associates and the chief medical officer of West Penn Hospital. Prairie has specialized in menopausal medicine for more than 15 years and said the approval of Veozah will open up a whole new possibility for patients who cannot benefit from hormone therapy.
Veozah, from Japan-based Astellas Pharma, is part of a class of medications called NK3 antagonists — NK3 is a kind of receptor that controls brain cells called KNDy neurons. When women age and estrogen levels plummet, NK3 goes into overdrive, said Dr. Katherine Scruggs, an OBGYN at the University of Pittsburgh Department of Women’s Health. The body thinks it’s hotter than it is, so it responds accordingly, leading to hot flashes.
Veozah can stop this pathway by blocking receptors in the brain’s hypothalamus, a region that keeps body temperature in check.
Research has shown that the hypothalamus is implicated in hot flashes. KNDy neurons, which live in the hypothalamus, act like switches for hot flashes. When a patient takes a Veozah pill, it blocks KNDy neurons from firing, thus stopping hot flashes.
During a hot flash, in addition to a sudden feeling of warmth, women may experience sweating and reddened skin.
It was only 10 years ago when women scientists discovered how hot flashes happened in the body, said Prairie. Menopausal specialists have known about NK drugs like Veozah for years now, she said, closely following the clinical trials where the drug was tested.
Those trials, called the SPIRIT trials, enrolled thousands of women over multiple years and found that Veozah worked to prevent hot flashes. Minor side effects accompany the drug, including headaches and gastrointestinal indications, symptoms Prairie said are fairly common even with placebos.
The contraindication to watch out for is how the drug impacts the liver. Women who have liver disease, such as cirrhosis, or kidney disease, should not take Veozah. The plan is for physicians to check patient liver enzyme levels before beginning the medication, and to continue to check levels intermittently. Veozah also interacts with certain drugs, such as the antibiotic Cipro and related medicines.
While hormone therapy works well to treat hot flashes, not everyone can take these medications — they come with risks, and women with hormone-related cancers, like estrogen receptor-positive breast cancer, cannot take hormones, including estrogen, to control hot flashes.
“I hope that (Veozah) gives us another option for patients that are really hit hard by their menopause symptoms,” Scruggs said.
“This is another alternative, another tool in the toolbox,” said Dr. Roberta Renzelli-Cain, a menopause specialist and OBGYN in Morgantown, West Virginia, and an associate professor of obstetrics and gynecology at WVU School of Medicine. “Everybody is super excited about this medication.”
In medical school, Renzelli-Cain said she was taught to tell women not to worry about hot flashes — that they would go away. But certain women, deemed “super-flashers,” struggle with hot flashes for many years, some for the rest of their lives. Super-flashers are also at a higher risk for heart disease, said Renzelli-Cain, which means they can’t take hormone therapy long-term.
“This medication has a lot of promise for [super-flashers], because they can stay on it longer,” she said.
Physicians expect Veozah to become available in as little as three weeks, but it is not yet known how widely covered the drug will be by insurance companies. Renzelli-Cain expects that some commercial insurance plans will cover it, but in a region like Morgantown, where around 50% of people are on Medicaid, doctors worry about the drug’s cost and accessibility.
“I’m hearing that it’s going to be one of these niche drugs where you have to have the golden insurance plan,” she said. “There will be a lot of folks who aren’t going to be able to take advantage of this.”
Without insurance, the drug is expected to cost $550 for a 30-day supply.
Further complicating the potential accessibility issue is robust data from the clinical trials that Veozah works well among many demographics, including Black women, who are more likely to be super-flashers and are at higher risk for heart disease.
The approval still represents a turning point in menopausal treatment.
“If you are having symptoms of menopause that are interfering with your capacity to get through daily life, we have options,” said Prairie. “Please talk to your gynecologist about it.”
Renzelli-Cain stressed that menopause treatment should be a time investment — not like treating strep throat with one pill, but like treating pregnancy, with multiple doctor visits.
“This is a great time for women to maximize their health,” she said.
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