FDA Approves New Drug to Treat Hot Flashes

Why It Matters: There are few harmless antidotes

Periodic overheating is a common symptom of menopause, which Astellas suggests affects at least 60 percent of women.

“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, an official with the F.D.A. Center for Drug Evaluation and Research.

They can be prolonged and interfere with basic functions in daily life.

Hormonal treatments including estrogen and progestin were linked to elevated risks of blood clots and strokes decades ago, but further study has shown that the risks are far lower in women in their 40s and 50s.

Background: Symptoms have long been endured

Hot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said.

And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere.

“It’s distracting,” Ms. English said. “It’s uncomfortable. It’s something that we kind of managed in silence.”

In yearlong studies, the drug was found to be effective and generally safe, with side effects including stomach pain, diarrhea and insomnia, according to the F.D.A.

Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. said patients should have blood work conducted before starting the medication to test for existing liver problems and should then repeat the tests during the first nine months of taking the drug.

“Patients experiencing symptoms related to liver damage — such as nausea, vomiting or yellowing of the skin and eyes — should contact a physician,” the F.D.A. statement says.

What’s Next: The drug price may be prohibitive

Astellas said that the drug would cost $550 for a 30-day supply, not including rebates. The company said it would begin a support program “to help patients access the medication they were prescribed.” The Institute for Clinical and Economic Review advised a lower price of $2,000 to $2,600 per year.

Ms. English said Astellas was prepared to have the medication in pharmacies within three weeks of approval.