WASHINGTON (AP) — US health regulators on Friday approved a new medication for women suffering from the uncomfortable hot flashes of menopause.
The Food and Drug Administration (FDA) has given the go-ahead for a once-daily pill from Astellas Pharma to treat moderate to severe symptoms, which may include sweating, redness of the skin and chills.
Astellas’ drug, Veozah, uses a new strategy because it targets connections in the brain that help control body temperature. The drug will provide “an additional safe and effective treatment option for women,” the FDA said in a statement.
More than 80% of women experience hot flashes during menopause, the FDA noted, because the body gradually produces lower levels of reproductive hormones between ages 45 and 55.
The most common treatment is hormone pills that increase estrogen and progestin levels. But the treatment is not suitable for some women, such as those with a history of stroke, blood clots, heart attack and other health problems. Large studies have found that hormones can increase the chances that these problems will occur again, although the risks vary depending on a number of individual factors.
The new pill is not a hormone. The drug carries the FDA warning that it can damage the liver. Women should be tested for liver damage or infection before they are prescribed. They will then have to have blood tests every three months for nine months to monitor safety, according to the FDA label.
Astellas said a month’s worth of medication will cost $550. That price is before insurance coverage and other discounts often negotiated by insurers and pharmaceutical benefit managers.
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