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Astellas reports Phase III data of fezolinetant for menopause-linked VMS

The AEs in the MOONLIGHT 3 trial were found to be generally in line with those seen in prior Phase III trials of fezolinetant.

Astellas Pharma has reported topline findings from the Phase III MOONLIGHT 3 clinical trial of fezolinetant to treat moderate to severe vasomotor symptoms (VMS) linked to menopause in women in mainland China. 

The single-arm trial analysed the long-term safety and tolerability of 30mg fezolinetant given once a day for 52 weeks for providing relief of menopause-linked VMS. 

It enrolled 150 women in mainland China.

The frequency and severity of adverse events (AEs) was the trial’s primary endpoint.

According to the findings, the AEs were found to be generally in line with those seen in prior Phase III trials of fezolinetant. 

An oral, nonhormonal compound, fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. 

A New Drug Application for fezolinetant to treat moderate to severe VMS linked to menopause is currently being reviewed in the US. 

This submission is based on findings from the Phase III SKYLIGHT 1 and SKYLIGHT 2 trials, as well as the Phase III SKYLIGHT 4, a long-term safety trial.

Astellas Development Therapeutic Areas senior vice-president and head Ahsan Arozullah said: “The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. 

“We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area, with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS.”

VMS are characterised by hot flashes and/or night sweats and are prevalent menopause symptoms.

In February last year, the company reported positive data from the Phase III SKYLIGHT 1 and SKYLIGHT 2 trials of fezolinetant  to treat moderate to severe menopause-associated VMS.

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