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A few comments on Elisabeth Mahase's news item about the recently approved drug fezolinetant.
The efficacy of fezolinetant has been tested through three randomised controlled phase 3 trials, (NCT04003155, NCT04003142 and NCT04003389).
The MHRA did state that the safety of fezolinetant has been studied in 2203 women, but did not make it clear that half of those taking the active product were taking only 30mg daily, (rather than the newly licenced 45mg tablets which might be predicted to have a less favourable adverse events profile).
The FDA concluded that women taking placebo had about two more hot flushes per day compared to those taking fezolinetant 45mg. (1)
The drug costs about $550 In USA (£430, €500) for a month's supply (2).
Another Pill Approved
Dear Editor
A few comments on Elisabeth Mahase's news item about the recently approved drug fezolinetant.
The efficacy of fezolinetant has been tested through three randomised controlled phase 3 trials, (NCT04003155, NCT04003142 and NCT04003389).
The MHRA did state that the safety of fezolinetant has been studied in 2203 women, but did not make it clear that half of those taking the active product were taking only 30mg daily, (rather than the newly licenced 45mg tablets which might be predicted to have a less favourable adverse events profile).
The FDA concluded that women taking placebo had about two more hot flushes per day compared to those taking fezolinetant 45mg. (1)
The drug costs about $550 In USA (£430, €500) for a month's supply (2).
1) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216578Orig1s000M...
2) https://www.theguardian.com/society/2023/dec/18/veoza-fezolinetant-menop...
Competing interests: No competing interests