Astellas' Veoza Receives Positive CHMP Opinion For Treatment Of VMS Associated With Menopause

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion relating to the use of Veoza(fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause.

vasomotor symptoms or VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.

If approved by the European Commission, fezolinetant will be a first-in-class, nonhormonal treatment option to reduce moderate to severe VMS associated with menopause, the company said in a statement.

Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron, helping restore the balance in the brain's temperature control center to reduce the number and intensity of hot flashes and night sweats.

The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.

The EC has 67 days from the CHMP opinion to issue a final decision. Additionally, the positive opinion allows the submission of a European Commission Decision Reliance Procedure marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA), which has the authority to approve medicines for England, Wales and Scotland following the UK's transition from the European Union. A final MHRA decision is anticipated in the coming months.

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