The US Food and Drug Administration approved Astellas Pharma's Veozah (lasofoxifene) for treating moderate to severe hot flashes associated with menopause. Veozah is a nonhormonal neurokinin 3 (NK3) receptor and is the first and only nonhormonal treatment approved by the FDA for this indication.
Before menopause, there is a balance between estrogens and neurokinin B. However, after menopause, estrogens will be reduced, leading to the brain's deregulation of body temperature control. The deregulation leads to vasomotor symptoms.
The FDA approval of Veozah was based on BRIGHT SKY progrram, which included three Phase 3 trials. SKYLIGHT 1 and SKYLIGHT 2 are two Phase 3, placebo-controlled, double-blind trials. SKYLIGHT 4 is a safety which further determines the long-term safety.
Veozah has reduced the number significantly and severity of hot flashes compared to a placebo in clinical trials.
Astellas plans to launch Veozah in the United States later this year.