taking Veozah as soon as possible and get back on schedule to help keep hot flashes at bay, the FDA said.
The agency based its approval on the results of two phase 3 clinical trials involving women who averaged 54 years of age. Women first took either Veozah or placebo for 12 weeks — the trial was “blinded,” meaning the women were not told which regimen they were receiving. Then all women were given Veozah for an additional 40 weeks to assess safety.
Are there any side effects?
“The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush [flashes],” the agency said.
There was also a risk of elevated hepatic transaminase, or liver injury, so “before using Veozah, patients should have blood work done to test for liver damage or infection,” the FDA said. “While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication.”
Veozah is made by Astellas Pharma US, Inc. Speaking with The New York Times, Marci English, a vice president at Astellas, called hot flashes “distracting” and “uncomfortable.”
“It’s something that we kind of managed in silence,” she shares. English says Astellas hopes to have Veozah in pharmacies within the next three weeks, and the drug will cost about $550 for a 30-day supply, before any rebates. According to the Times, Astellas says it would begin a support program “to help patients access the medication they were prescribed.”