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CompilationFan Dongdong
A few days ago, Astellas’s $550 million bet on menopause drug fezolinetant suffered a setback
The MOONLIGHT 1 trial, an ongoing randomized Phase 3 clinical trial, enrolled 302 female patients in Mainland China, Taiwan, and South Korea who were randomly assigned to receive a 30 mg dose of fezolinetant or placebo , for 24 weeks
Results of the trial showed that after 12 weeks, women in the fezolinetant-treated group had an improvement in hot flashes from baseline, but the difference was not statistically significant compared to women in the placebo group
It is unclear why fezolinetant failed to beat placebo in Asian trials
In 2017, Astellas announced the completion of the $550 million acquisition of Belgian biotech company Ogeda, through which Astellas acquired fezolinetant
For now, the regulatory conundrum for Astellas is how long the impact of the consequences of this trial failure will last
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