Another study win for Bayer’s elinzanetant puts Astellas' Veozah firmly in its sights

2024-03-19

临床结果临床3期

Bayer reported further positive Phase III study results for elinzanetant in treating severe vasomotor symptoms (VMS) associated with menopause, but the wait continues for detailed data to see how the NK-1,3 receptor antagonist stacks up against Astellas' marketed drug Veozah (fezolinetant).

In January, Bayer announced that elinzanetant met the primary endpoints of the OASIS 1 and 2 trials in women with VMS associated with menopause, with the oral drug demonstrating statistically significant reductions in the frequency and severity of moderate-to-severe VMS from baseline to week four and 12 compared to placebo.

Meanwhile, the results disclosed Tuesday come from the OASIS 3 study, with elinzanetant again demonstrating a statistically significant reduction in the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo. Bayer added that the long-term safety profile observed over 52 weeks in the trial was “overall consistent” with previously conducted studies.

Results from all three OASIS studies are expected to be presented at upcoming medical meetings, with elinzanetant’s safety profile seen as key to competing with Astellas’ NK3 receptor antagonist. Veozah’s label in the US includes a warning for elevated hepatic transaminase and requires blood tests for liver damage or infection prior to treatment and every three months for the first nine months of use.

Bayer said it will submit the data from the OASIS programme to health authorities seeking approval of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause.

More to come.

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