The Food and Drug Administration has approved
a new nonhormonal oral drug, under the brand name Veozah, designed to treat
menopausal hot flashes.
اضافة اعلان
The drug provides women with a “safe and
effective treatment option,” Dr. Janet Maynard, director of the FDA Office of
Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, said in a
statement.
Hot flashes, also called vasomotor symptoms,
affect roughly 75 percent of menopausal and perimenopausal American women.
Impact on quality of life and productivity
A large body of evidence suggests that this
symptom, in which a woman feels suddenly and overwhelmingly hot, can have a
serious impact on quality of life and productivity. Studies have found that
Black women suffer from more severe and frequent hot flashes for longer
durations.
Yet there have been few safe and effective
treatment options for hot flashes, said Dr. Stephanie Faubion, medical director
for the North American Menopause Society and a director of the Mayo Clinic
Center for Women’s Health. Hormone therapy is the most effective treatment for
women under age 60, but it presents risks for women with certain health
conditions.
Misconceptions about it, which are largely
rooted in a study from 2002 that has since been challenged, steered many other
women away from it, she said.
There is only one other nonhormonal treatment
that has been shown to effectively manage hot flashes. It is paroxetine, which
is primarily used to treat depression but was approved by the FDA to be used
for menopause symptoms too.
Unmet need
Decades of limited treatment options created a
gaping “unmet need,” making Veozah, which is produced by the Japanese pharmaceutical
company Astellas, both groundbreaking and long overdue, said Dr. Lauren
Streicher, a clinical professor of obstetrics and gynecology at Northwestern
University and medical director of the Northwestern Medicine Center for
Menopause.
“When you think about the impact of vasomotor
symptoms on work, on cognitive function, on sleep, on quality of life — the
availability of another option is exciting,” she said. “This is something we’ve
been anticipating for a long time.”
About a decade ago, researchers identified
neurons in the brain, known as KNDy neurons, that regulate body temperature,
and found that those neurons were primarily controlled by estrogen. When women
transition to menopause and their estrogen levels fall, “these neurons go into
overdrive,” Streicher said, perceiving the body to be hotter than it is and
thus setting off a cascade of events to cool the body down, like sweating.
Veozah contains a compound called
fezolinetant, which binds to those neurons and “calms them down,” Streicher
said.
Astellas conducted three trials for Veozah at
test sites in Canada, the US, and countries in Europe and collectively involved
over 3,000 women who had moderate or severe hot flashes.
A significant reduction
Compared with a placebo, the drug
significantly reduced the severity and frequency of hot flashes for women who
took one pill a day.
Many women taking the drug reported a
difference by week four. In some cases, said Dr. Nanette Santoro, a professor
of obstetrics and gynecology at University of Colorado School of Medicine, who
was a scientific adviser for Astellas during trials of the drug, women reported
feeling a difference in a week.
There are still no studies comparing the
efficacy of fezolinetant with that of estrogen — which can reduce frequency of
hot flashes by 75 percent, Faubion said — but it seems to be more effective
than paroxetine.
The trial included women ages 40 to 65 and the
drug was effective across those age groups. But it might be particularly
helpful for women over 60 because at that age, starting hormonal treatments can
be considered risky, making it “potentially a very, very good option” for those
women, said Streicher, who was not involved with the study but reviewed its
findings.
“The other thing that’s nice about the
clinical trials is they had a good cross-section of women — Black women, Asian
women, Latina women,” she said. “And it worked just as well in Black women as
in white women — that’s huge.”
One of the main concerns going into the trial
was liver toxicity. Similar versions of the drug produced by other companies
found that to be a major side effect and those trials were discontinued,
Santoro said.
Across the drug’s three trials, 25 women
showed elevated liver enzymes, according to the FDA’s safety statement. For
this reason, women with known liver damage should avoid the drug and the FDA
recommends doing blood work before starting the medication to screen for liver
damage. It is also not safe for patients with known kidney failure or kidney
disease.
There are “still a lot of unknowns” about the
drug, Faubion said, particularly any effects on “heart health, bone health,
sexual health, mood symptoms or weight.” That, she added, is difficult to gauge
fully until the drug is on the market and used by more people for longer
durations. Only estrogen, Faubion noted, has been shown to provide other
long-term health benefits beyond mitigating hot flashes.
The company has said that the product will be
available in pharmacies soon and will cost $550 for a 30-day supply.
That price is prohibitively expensive, Faubion
said, and may not be covered by insurance companies. “This needs to be
affordable so women can really utilize it,” she said.
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