FDA Approves New Menopause Drug for Hot Flashes

WASHINGTON — U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause.

The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.

Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.

More than 80% of women experience hot flashes during menopause, the FDA noted, as the body gradually produces lower levels of reproductive hormones between the ages of 45 and 55.

The most common treatment consists of hormonal pills aimed at boosting levels of estrogen and progestin. But the treatment isn’t appropriate for some women, including those with a history of stroke, blood clots, heart attack and other health conditions. Large studies have found that the hormones can increase the chances of those problems reoccurring, although the risks vary based on a number of individual factors.

The new pill is not a hormone. It carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.

Astellas said the drug will cost $550 for a one-month supply. That’s the price before insurance coverage and other discounts typically negotiated by insurers and pharmacy benefit managers.