The Food and Drug Administration on Friday approved the first non-hormonal drug to treat hot flashes in menopausal women, offering a potential remedy for symptoms of upper body overheating and sweating, which can disrupt daily life for years.
The drug, to be marketed as Veozah, is the first to target a neuron in the brain that becomes imbalanced when estrogen levels drop. Typically, it would be prescribed to women in their 50s during the estimated seven-year menopausal phase, according to Marci English, vice president of Astellas Pharma, the drug’s maker.
The agency said the drug was cleared for moderate to severe symptoms.
Why it matters: There are few harmless antidotes
Periodic overheating is a common symptom of menopause, which Astellas suggests affects at least 60% of women.
“Hot flashes as a result of menopause can be a serious physical burden for women and affect their quality of life,” said Dr. Janet Maynard, an official at the FDA’s Center for Drug Evaluation and Research.
They can be prolonged and interfere with basic functions of daily living.
Hormone treatments, including estrogen and progestin, were associated with increased risks of blood clots and stroke decades ago, but later studies have shown that the risks are much lower in women in their 40s and 50s.
Background: Symptoms are borne for a long time
Hot flashes are the most common side effect of menopause for which women often seek treatment, Astellas said.
And the complaints of those who experience hot flashes and other menopausal symptoms are often dismissed in the workplace and elsewhere.
“It’s a distraction,” said Mrs. English. “It’s uncomfortable. It’s something that we kind of achieved in silence.”
In one-year studies, the drug was shown to be effective and generally safe, with side effects such as stomach pain, diarrhea and insomnia, according to the FDA.
As signs of liver damage emerged in some patients during the drug’s study, the FDA said patients should have blood tests before starting the drug to test for existing liver problems and repeat the tests during the first nine months of using the drug. .
“Patients with symptoms related to liver damage — such as nausea, vomiting, or yellowing of the skin and eyes — should contact a physician,” the FDA statement reads.
What’s next: The price of the drug can be prohibitive
Astellas said the drug would cost $550 for a 30-day supply, not including rebates. The company said it would start a support program “to help patients access their prescription drugs.” The Institute for Clinical and Economic Review advised a lower price of $2000 to $2600 per year.
Mrs. English said Astellas was prepared to have the drug in pharmacies within three weeks of approval.