Dubai, United Arab Emirates (CNN) – The US Food and Drug Administration (FDA) on Friday granted the green light to a new type of drug for the treatment of hot flashes and night sweats during menopause.
Veozah, or “fezolinetant”, from Astellas Pharma is the first approved drug to combat neurokinin 3 (NK3).
The drug blocks receptors in the brain that play a role in regulating body temperature.
It also replaces traditional therapies with replacement hormones designed to deal with hot flashes, a common symptom of menopause.
And they can be tiring if they get too intense.
Sometimes, women at risk of stroke, heart attack, or some types of cancer are advised not to undergo hormone replacement therapies, as they increase the risk of blood clots and cancers.
In a press release, Dr. Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine at the FDA’s Center for Drug Evaluation and Research, said, “Symptoms of menopausal hot flashes can be physically dangerous for a woman. and affect their quality of life.”
“Introducing a new molecule for the treatment of moderate to severe hot flashes due to menopause could provide an additional safe and effective treatment option for women,” Maynard added.
Menopause, which is a normal period in women’s lives, usually begins in the mid-40s.
During this period, the body produces less estrogen and progesterone.
The decrease in these hormones may lead to disturbed sleep, mood swings, and suffering from hot flashes that translate through sweating, flushing, and a feeling of chills.
It can last for several minutes.
In clinical trials involving more than 3,000 women in the United States and Canada, Veozah reduced the number of hot flashes women experienced per week when compared to a placebo.
The study followed the women who used the drug for a year.
“I think at the end of the day, it’s always good for women to have more choices, so I’m excited to see more progress in an area that’s been neglected, namely,” said Stephanie Faubion, M.D., director of the Mayo Clinic Center for Women’s Health, who was not involved in the development of Veozah. Medicine related to menopause”.
According to Phoebe, short-term hormone replacement therapy remains the most effective and least expensive option for dealing with hot flashes for many women.
Hormone replacement therapy gained notoriety in 2002, after a government-funded health study discovered that it could increase the risk of cancer and blood clots.
A report released in December by the Institute for Clinical and Economic Review (ICER) rated the clinical evidence supporting the drug as promising, but the drug was inconclusive when it came to providing a net benefit compared to no drug treatment at all.
The institute concluded that the drug would be cost-effective for women who cannot undergo hormone replacement therapy, or who choose not to undergo it because of its cost.
Astellas announced Friday that the drug’s pre-insurance price will be $550 per month.
Veozah comes with a warning about risks associated with liver injury.
And the US Food and Drug Administration recommended that women considering using it should undergo blood tests to ensure that they have not suffered any damage or liver injury before starting to take it.
They should also be monitored with blood tests every 3 months for the first 9 months to make sure there are no signs of liver damage from taking the medication.
2023-05-16 10:24:47
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