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UK clears the way for drug that treats hot flushes in menopausal women

A groundbreaking drug offering potential relief to countless women grappling with menopausal hot flushes has secured approval in the UK. Known as Veoza or fezolinetant, the drug has been greenlit by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), following its clearance for use by the US Food and Drug Administration in the United States.

Menopausal hot flushes affect approximately 70% of women globally, exerting a detrimental impact on their daily lives by disrupting activities such as exercise and sleep, as reported by The Guardian. While hormone replacement therapy (HRT) stands as the most effective treatment for hot flushes, certain factors—ranging from side effects to medical history—render it unsuitable for everyone, prompting a demand for non-hormonal alternatives.

Veoza, positioned as a non-hormonal menopause drug, directly targets the brain to alleviate hot flushes by inhibiting a protein called neurokinin-3. Although not recommended for women over 65, Veoza offers potential relief for individuals for whom HRT is not a viable option.

The cost of treatment in the UK is yet to be determined, but in the US, it amounts to $550 (£430) for a 30-day supply. Veoza operates directly on the brain’s temperature control pathway without replacing estrogen, presenting a novel approach to addressing moderate to severe vasomotor symptoms associated with menopause.

Clinical trials of Veoza showcased a remarkable 60% reduction in the frequency of hot flushes after 12 weeks of use among women with moderate or severe symptoms. Experts have lauded Veoza as a “completely blockbuster drug.”

Julian Beach, the interim executive director of healthcare quality and access at MHRA, expressed satisfaction with authorizing Veoza, acknowledging the commonality and impact of menopausal symptoms on women’s daily lives. Beach emphasized that no medicine would receive approval unless it met the expected standards of safety, quality, and effectiveness, underscoring ongoing vigilance in monitoring medicine safety.

As a prescription-only drug, Veoza is set to be available privately starting January 5, according to Astellas, the pharmaceutical company behind the development. Astellas is concurrently pursuing access through the National Institute for Health and Care Excellence to make Veoza available on the NHS, heralding a potential breakthrough in addressing a prevalent and challenging aspect of women’s health.

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