New drug for menopausal hot flashes receives FDA approval
WASHINGTON (AP) – U.S. health officials on Friday approved a new type of drug for women struggling with uncomfortable hot flashes associated with menopause.
The Food and Drug Administration has approved Astellas Pharma’s once-a-day pill to treat moderate to severe symptoms, which can include sweating, flushing, and chills.
Astellas’ drug, Veozah, uses a new approach that targets brain connections that help control body temperature. The FDA said in a statement that the drug will represent “an additional safe and effective treatment option for women.”
The FDA found that more than 80% of menopausal women experience hot flashes because the body gradually produces fewer reproductive hormones between the ages of 45 and 55.
The most common treatment consists of hormone pills aimed at increasing estrogen and progestin levels. However, the treatment is not suitable for some women, particularly those with a history of stroke, blood clots, heart attacks, or other health problems. Large studies have found that the hormones can increase the likelihood of these problems coming back, although risks can vary based on a number of individual factors.
The new pill is not a hormone. It includes an FDA warning of possible liver damage. According to the FDA label, women must be screened for liver damage or infection before receiving a prescription and then have blood tests every three months for nine months to watch for safety issues.
Astellas said the drug will cost $550 for a month. That’s the price before insurance coverage and other discounts typically negotiated by insurers and benefit managers at pharmacies.
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