Astellas’ first non-hormonal menopause therapy TGA approved

Pharma News: A first-of-its-kind non-hormonal treatment has been approved for use in Australia for the treatment of moderate to severe vasomotor symptoms (VMS), commonly referred to as hot flushes and night sweats, associated with menopause. The non-hormonal aspect of Astellas‘ selective neurokinin-3 receptor antagonist, Veoza (fezolinetant), is key because some people with menopause cannot take hormone therapies.

Professor Rodney Baber, Head of Menopause and Menstrual Disorders Clinic at the Royal North Shore Hospital in Sydney, said “We know that stigma and other barriers prevent many women from having conversations with their doctor. Hot flushes and night sweats associated with menopause can be very disruptive, affecting a person’s sleep, mood, energy and overall quality of life, with some women experiencing symptoms for ten years or more.”

Despite these profound impacts, a study of Australian women aged 40-64 years showed that 85% of women with moderate to severe VMS are not currently receiving treatment, or around 385,000 women.

The approval was supported by the results of three phase 3 trials, including a longer-term safety study, which showed the drug’s ability to prevent hot flashes. Astellas has also reported the failure of Veoza in a late-stage study of patients in Asia, including China, Korea and Taiwan.

Astellas acquired Veoza in its 2017 takeover of Ogeda for 500 million euros ($550 million) upfront plus a potential 300 million euros in milestones. In 2020, Bayer joined Astellas in the race by paying $425 million upfront to buy KaNDy Therapeutics for neurokinin-1,3 receptor antagonist NT-814. 

Christine Kemp, Senior Medical Lead at Astellas Australia, said “Today’s approval marks an important step in increasing the choices available to women experiencing some of the most bothersome symptoms of menopause.”

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