The FDA has given the thumbs up to a novel medicine, Veozah (also known as fezolinetant), designed to alleviate menopausal symptoms such as hot flashes and night sweats. Created by Astellas Pharma, Veozah is a pioneer in the medical world as the inaugural neurokinin 3 (NK3) agonist to gain approval.
This innovative medication functions by inhibiting receptors in the brain involved in body temperature regulation, presenting a fresh option beyond standard hormone replacement treatments. These traditional therapies are often unsuitable for women with elevated risks of stroke, heart disease, or specific types of cancer, due to their potential to heighten risks of blood clots and cancers.
Dr. Janet Maynard, who oversees the FDA's Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Center for Drug Evaluation and Research, emphasized the significance of this development. She pointed out the serious physical toll that menopausal hot flashes can take on women, affecting their quality of life significantly. The arrival of this novel compound for managing moderate to severe hot flashes offers an additional safe and effective option for women's health care.
Menopause, a natural phase in a woman's life, typically starts in the mid-to-late 40s. As the body's production of estrogen and progesterone dwindles during this time, symptoms such as sleep disturbances, mood fluctuations, and hot flashes can occur. Hot flashes, which are episodes of sweating, flushing, and chills lasting several minutes, are particularly common.
Clinical trials involving over 3,000 women in the US and Canada showed promising results for Veozah. Women taking the drug witnessed a significantly greater reduction in the frequency of hot flashes each week compared to those given a placebo. These studies tracked the women's experiences over a year of taking the medication.
However, Veozah does come with a caution about the potential for liver injury. The FDA advises women considering this medication to undergo blood tests for any existing liver damage or infection before starting the treatment. Furthermore, they should continue to have blood tests every three months during the course of the medication to monitor for any signs of liver damage.
The trials reported that the most frequently experienced side effects were abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated liver enzymes.
Regarding the cost, Astellas Pharma has stated that Veozah will be priced at $550 per month prior to any insurance contributions. However, the company anticipates broad coverage from insurance providers.
Q&A Section:
Question: What is the new drug approved by the FDA for treating menopausal symptoms?
Answer: The FDA has recently approved a new drug called Veozah (or fezolinetant) for treating menopausal symptoms like hot flashes and night sweats.
Question: What makes Veozah a unique drug for treating menopausal symptoms?
Answer: Veozah, made by Astellas Pharma, is unique because it's the first approved neurokinin 3 (NK3) agonist. It works by blocking receptors in the brain that regulate body temperature, providing an alternative to traditional hormone replacement therapies.
Question: What is the cost of Veozah and is it covered by insurance?
Answer: Astellas Pharma, the manufacturer of Veozah, has stated that the drug will cost $550 per month before insurance. However, the company expects that the medication will be widely covered by insurance providers.
Question: Are there any warnings associated with Veozah?
Answer: Yes, Veozah comes with a warning about the potential risk of liver injuries. The FDA advises women considering this medication to have blood tests to check for any liver damage or infection before starting the treatment. They should also be monitored with blood tests every three months to ensure they don't show signs of liver damage while taking the drug.
Question: How effective is Veozah in treating menopausal symptoms?
Answer: In clinical trials involving over 3,000 women in the US and Canada, Veozah significantly reduced the number of hot flashes women experienced each week compared to a placebo. These studies tracked women who took the drug for a year.
