Bayer: EMA submission for elinzanetant

(CercleFinance.com) - Bayer announced on Tuesday that it had submitted a marketing authorization application to the European Medicines Agency (EMA) for elinzanetant, its new drug for menopause-related disorders.


The German laboratory says that its application is based on favourable Phase III data showing a reduction in the frequency and severity of moderate to severe vasomotor symptoms compared with placebo in postmenopausal women.

Elinzanetant acts by modulating a group of estrogen-sensitive neurons in the brain's hypothalamus which lead to hyperactivation of the thermoregulatory system, thus disrupting body heat regulation mechanisms and causing sleep disturbances.

According to a recent study, 67% of menopausal women suffer from these symptoms.

Bayer has also submitted marketing applications for its tablet in Australia, Canada, Switzerland, the UK and the US.


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