Bayer files for MHRA approval of elinzanetant

17 September 2024

German pharma major Bayer (BAYN: DE) has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women.

The submission, which adds to one with the US regulator last month, is based on the positive results from the Phase III OASIS 1, 2 and 3 studies.

In 2023, the global market for VMS – also known as hot flashes - treatments was valued at approximately $16.6 billion and is expected to grow to $17.86 billion in 2024.

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