WASHINGTON — U.S. well being regulators on Friday authorized a brand new sort of drug for girls coping with uncomfortable sizzling flashes attributable to menopause.
The Food and Drug Administration authorized the once-a-day capsule from Astellas Pharma to deal with moderate-to-severe signs, which might embody sweating, flushing and chills.
Astellas‘ drug, Veozah, makes use of a brand new strategy, focusing on mind connections that assist management physique temperature. The FDA stated the treatment will present “an additional safe and effective treatment option for women,” in a press release.
More than 80% of girls expertise sizzling flashes throughout menopause, the FDA famous, because the physique steadily produces decrease ranges of reproductive hormones between the ages of 45 and 55.
The commonest therapy consists of hormonal drugs geared toward boosting ranges of estrogen and progestin. But the therapy isn’t applicable for some girls, together with these with a historical past of stroke, blood clots, coronary heart assault and different well being circumstances. Large research have discovered that the hormones can improve the probabilities of these issues reoccurring, though the dangers fluctuate based mostly on a variety of particular person components.
The new capsule is just not a hormone. It carries an FDA warning about potential liver harm. Women will should be screened for liver harm or an infection earlier than getting a prescription, then get a blood check each three months for 9 months to watch for security issues, in response to the FDA label.
Astellas stated the drug will value $550 for a one-month provide. That’s the value earlier than insurance coverage protection and different reductions sometimes negotiated by insurers and pharmacy profit managers.
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