WASHINGTON — U.S. well being regulators on Friday accredited a brand new kind of drug for girls coping with uncomfortable scorching flashes attributable to menopause.
The Meals and Drug Administration accredited the once-a-day tablet from Astellas Pharma to deal with moderate-to-severe signs, which might embrace 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 “a further secure and efficient therapy choice for girls,” in a press release.
Greater than 80% of girls expertise scorching 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 capsules aimed toward boosting ranges of estrogen and progestin. However the therapy isn’t acceptable for some girls, together with these with a historical past of stroke, blood clots, coronary heart assault and different well being circumstances. Giant research have discovered that the hormones can enhance the possibilities of these issues reoccurring, though the dangers fluctuate primarily based on a variety of particular person components.
The brand new tablet is just not a hormone. It carries an FDA warning about potential liver injury. Girls will should be screened for liver injury 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 keeping with 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 usually negotiated by insurers and pharmacy profit managers.
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