Astellas Pharma launches new drug to treat hot flashes and night sweats associated with menopause Approved by FDAa regulatory decision to make this therapy the first therapy to reach specific central nervous system targets to relieve symptoms of this change in life.
The drug fezolinetant, which was approved on Friday, is intended for the treatment of moderate to severe vasomotor symptoms caused by menopause. Tokyo-based Astellas Pharma will market the once-daily tablet under the brand name Veozah. The company said in an email that wholesale prices for the new drug will be $550 for a 30-day supply. Astellas expects Veozah to be available within three weeks of him.
After menopause, estrogen and progesterone production declines. The resulting hormonal imbalance can affect how the body regulates temperature, causing hot flashes, a sudden, intense feeling of heat. Hormone therapy is standard treatment for these vasomotor symptoms, but these therapies can increase the risk of stroke, blood clots, and heart attack. Some women with a history of cardiovascular disease may not be candidates for hormone therapy. Astellas provides them with a new non-hormonal option.
Veozah is a small molecule designed to block neurokinin 3 (NK3). Located in the central nervous system, the role of this receptor includes thermoregulation. Astellas’ approval is based on the results of two placebo-controlled Phase 3 trials, each lasting 12 weeks. The primary aim of both was to measure changes in moderate to severe vasomotor symptoms. Across these studies, results showed that treatment with Veozah resulted in a statistically significant reduction in the severity and frequency of these symptoms. Here are the Phase 3 results: published It was published in The Lancet magazine in March.
After completing the 12-week study, participants proceeded to a 40-week extension study designed to further evaluate the safety of Veozah. Subjects in the treatment group continued to receive study drug. Participants who initially received placebo began treatment with Astellas. The most common side effects reported in studies included abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver enzyme levels.
Side effects of liver enzymes may be an indication of drug toxicity. Veozah’s label includes a warning that the drug may cause liver damage. The FDA said patients should have blood tests before starting treatment and periodically during treatment to monitor for liver problems. The agency added that Astellas should not be taken by patients with cirrhosis, severe renal failure or end-stage renal disease.
Veozah’s regulatory applications are still under review in the European Union, Switzerland and Australia. The FDA decision made Veozah the first NK3 inhibitor to be approved, but some companies are pursuing this goal as a way to alleviate symptoms of menopause. Bayer has reached Phase 3 trials of the drug Erinzanetant, acquired through its KaNDy Therapeutics acquisition in 2020. Acer Therapeutics has advanced its NK3-targeted drug candidate, osanetant, through Phase 2a trials. In March, the biotech company suspended the program for the following reasons: Preliminary data reporting We show that this drug did not lead to a statistically significant reduction in the frequency or severity of hot flashes compared to placebo.
Photo courtesy of Astellas Pharma Inc.
