The FDA granted approval to a novel class of medication on Friday for women experiencing painful hot flashes brought on by menopause.
The once-daily Astellas Pharma medication is approved by the Food and Drug Administration to treat moderate-to-severe symptoms, such as sweating, flushing, and chills. Veozah, a medication from Astellas, takes a novel strategy by going after the brain connections that regulate body temperature.
The drug will offer “an additional safe and effective treatment option for women,” according to a statement from the FDA.
The FDA stated that when the body gradually generates reduced quantities of reproductive hormones between the ages of 45 and 55, more than 80% of women experience hot flashes during menopause.
Hormonal supplements that increase levels of estrogen and progestin are the most widely used form of treatment.
However, some women—including those who have a history of stroke, blood clots, heart attack, and other medical conditions—do not respond well to the medication.
Despite the fact that the dangers vary depending on a variety of unique characteristics, large studies have indicated that hormones can raise the likelihood of those issues repeating.
There is no hormone in the new drug. The FDA has issued a warning regarding possible liver harm.
According to the FDA label, women will need to be checked for liver disease or infection before receiving a prescription, and they will then need to obtain blood tests every three months for nine months to check for safety issues.