WASHINGTON — U.S. well being regulators on Friday accredited a brand new kind of drug for ladies coping with uncomfortable sizzling 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 may embody sweating, flushing and chills.
Astellas’ drug, Veozah, makes use of a brand new method, concentrating on mind connections that assist management physique temperature. The FDA mentioned the treatment will present “an extra protected and efficient remedy possibility for ladies,” in a press release.
Greater than 80% of ladies 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 most typical remedy consists of hormonal tablets aimed toward boosting ranges of estrogen and progestin. However the remedy isn’t acceptable for some ladies, together with these with a historical past of stroke, blood clots, coronary heart assault and different well being circumstances. Massive research have discovered that the hormones can improve the probabilities of these issues reoccurring, though the dangers fluctuate based mostly on various particular person components.
The brand new tablet is just not a hormone. It carries an FDA warning about potential liver harm. Ladies will have to be screened for liver harm or an infection earlier than getting a prescription, then get a blood take a look at each three months for 9 months to observe for security issues, based on the FDA label.
Astellas mentioned the drug will price $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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