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Anvisa Approves First Non‑Hormonal Drug for Menopausal Hot Flashes

Blocking neurokinin B signaling in the hypothalamus, the oral drug provides a non‑estrogen treatment option for women unable or unwilling to use hormone therapy.

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Primeiro remédio não hormonal para 'fogachos' na menopausa é aprovado pela Anvisa

Overview

  • Anvisa granted approval for fezolinetanto, sold as Veoza by Astellas Farma, following the agency's review that concluded the drug is indicated for menopausal hot flashes and night sweats.
  • The decision was based on three phase‑3 trials of more than 3,000 people in Europe, the United States and Canada that showed reduced frequency and intensity of vasomotor symptoms and a favorable safety profile.
  • Fezolinetanto works by blocking the receptor for neurokinin B in the hypothalamus, which stabilizes the brain's temperature control and cuts sudden hot flashes without replacing estrogen.
  • The drug offers an option for patients who cannot take hormone therapy for reasons such as certain breast cancers or cardiovascular contraindications but does not treat bone loss or vaginal dryness.
  • Veoza is not yet on pharmacy shelves because final price-setting by the CMED and Astellas's launch timetable remain pending, and patient access will depend on those next steps.