But?….
The price for the medication is OFF the WALL ….
The News
The Food and Drug Administration on Friday approved the first nonhormonal medication to treat hot flashes in menopausal women, offering a potential remedy for the symptoms of overheating of the upper body and sweating that can be disruptive to daily life for years.
The drug, to be marketed as Veozah, is the first to target a neuron in the brain that becomes unbalanced as estrogen levels fall. It would typically be prescribed for women in their 50s during the menopausal phase estimated to last seven years, according to Marci English, a vice president of Astellas Pharma, the maker of the medication.
The agency said the drug was cleared for moderate to severe symptoms.
Why It Matters: There are few harmless antidotes
Periodic overheating is a common symptom of menopause, which Astellas suggests affects at least 60 percent of women.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Center for Drug Evaluation and Research.
They can be prolonged and interfere with basic functions in daily life.
Hormonal treatments including estrogen and progestin were linked to elevated risks of blood clots and strokes decades ago, but further study has shown that the risks are far lower in women in their 40s and 50s….
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What’s Next: The drug price may be prohibitive
Astellas said that the drug would cost $550 for a 30-day supply, not including rebates. The company said it would begin a support program “to help patients access the medication they were prescribed.” The Institute for Clinical and Economic Review advised a lower price of $2,000 to $2,600 per year.
Ms. English said Astellas was prepared to have the medication in pharmacies within three weeks of approval….