FDA approves new drug to treat hot flashes
The Food and Drug Administration on Friday approved the first non-hormonal drug to treat hot flashes in menopausal women, offering a potential cure for the symptoms of upper body heat and sweating that can disrupt daily life for years.
The drug, marketed as Veozah, is the first to target a neuron in the brain that becomes unbalanced when estrogen levels fall. According to Marci English, a vice president of Astellas Pharma, the drug’s maker, it would typically be prescribed to women in their 50s during the menopausal phase, which is estimated to last seven years.
The agency said the drug is approved for moderate to severe symptoms.
Why It Matters: There are few harmless antidotes
Periodic overheating is a common symptom of menopause, affecting at least 60 percent of women, Astellas says.
“Hot flashes associated with menopause can be a serious physical burden for women and affect their quality of life,” said Dr. Janet Maynard, FDA Center for Drug Evaluation and Research Associate.
They can last longer and affect basic functions of daily life.
Decades ago, hormone treatments containing estrogen and progestin were linked to an increased risk of blood clots and stroke. However, further studies have shown that the risk is far lower in women in their 40s and 50s.
Background: The symptoms have been endured for a long time
Hot flashes are the most common side effect of menopause that women typically seek treatment for, Astellas said.
And the grievances of those suffering from severe hot flashes and other menopausal symptoms are often dismissed in the workplace and elsewhere.
“It’s distracting,” said Ms. English. “It is uncomfortable. It’s something we’ve done quietly.”
Years of studies have shown the drug to be effective and generally safe, with side effects like stomach pain, diarrhea, and insomnia, according to the FDA
Because some patients developed signs of liver damage during the drug’s study, the FDA required that patients have a blood test to check for existing liver problems before starting the drug, and then repeat the tests for the first nine months of taking the drug .
“Patients who develop symptoms associated with liver damage — such as nausea, vomiting, or yellowing of the skin and eyes — should contact a physician,” the FDA statement said.
What’s next: Drug price could be prohibitive
Astellas said the drug would cost $550 for a 30-day supply, not including discounts. The company said it would launch a support program “to make it easier for patients to access the medicines they’ve been prescribed.” The Institute for Clinical and Economic Review recommended a lower price of $2,000 to $2,600 per year.
Ms English said Astellas is ready to have the drug in pharmacies within three weeks of approval.