FDA approves new drug to treat moderate to severe hot flashes associated with menopause


For immediate release:

Today, the U.S. Food and Drug Administration approved Veozah (fesolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA for the treatment of moderate to severe hot flashes associated with menopause. It works by binding to and blocking the activity of the NK3 receptor, which plays a role in thermoregulation in the brain.

“Hot flashes due to menopause can be a significant physical burden for women and impact their quality of life,” said Janet Maynard, M.D., director of Rare Diseases, Pediatrics, Urology and Reproductive Medicine at MHS. said in an FDA document. Center for Drug Evaluation and Research “The introduction of new molecules to treat moderate-to-severe menopausal hot flashes will provide additional safe and effective treatment options for women.”

Menopause is a normal and natural change in a woman’s life, usually occurring between the ages of 45 and 55, when menstruation stops. Menopause is often referred to as a “life change” or “change.” During menopause, a woman’s body gradually reduces the production of the hormones estrogen and progesterone. A woman reaches menopause when she has not menstruated for 12 consecutive months. Hot flashes occur in about 80% of menopausal women and may last for several minutes with sweating, flushing, and chills.

Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease may not be able to take hormone therapy. Veozah is not a hormone. Targets the neural activity that causes menopausal hot flashes.

Patients taking Veozah should take one 45-milligram tablet orally once daily, with or without food. Tablets should be taken at the same time each day. If a dose is missed or not taken at the usual time, the patient should take it as soon as possible and return to the usual schedule the next day.

The efficacy of Veozah for treating moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two Phase 3 clinical trials. In both trials, after her first 12 weeks, a 40-week extension trial was conducted in which the woman on placebo was again randomized to her Veozah to assess safety. . Each study ran for a total of 52 weeks. The average age of study participants was 54 years.

Prescribing information for Veozah contains warnings about elevated liver transaminases or liver damage. Before using Veozah, patients should have a blood test to check for liver damage. While taking Veozah, he should have regular blood tests every three months for her first nine months of using the drug. Patients with symptoms associated with liver damage, such as nausea, vomiting, and yellowing of the skin and eyes, should consult their doctor. Veozah cannot be used with her CYP1A2 inhibitor. Patients with known cirrhosis, severe kidney damage, or end-stage renal disease should not take Veozah.

The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver transaminases.

The FDA has granted priority review designation to the Veozah application.

Approval for Veozah has been granted to Astellas Pharma US, Inc.

Related information

###

fixed phrase

FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and animal drugs, vaccines and other biological products for humans, and medical devices. is protecting The agency is also responsible for regulating our country’s food supply, cosmetics, dietary supplements, the safety and security of electronic radiation emitting products, and tobacco products.




Source link

Leave a Reply

Your email address will not be published. Required fields are marked *