In a significant stride towards improving the quality of life for menopausal individuals, Veoza, a prescription-only drug also known as fezolinetant, has recently gained approval in the United Kingdom.
The green light from regulatory authorities marks a milestone in women’s health, offering a novel solution to alleviate the often debilitating symptoms of hot flushes.
Veoza, developed by leading pharmaceutical company Astella Pharma Inc., is set to revolutionise the management of hot flushes associated with menopause.
The approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) follows rigorous clinical trials that demonstrated the drug’s efficacy and safety in addressing this common yet distressing symptom.
Hot flushes, characterised by sudden and intense sensations of heat, sweating and a flushed face, are hallmark symptoms of menopause affecting a substantial percentage of women.
While they are a natural part of the ageing process, the impact on daily life can be profound, with many individuals experiencing disruptions to sleep, mood swings and a diminished overall quality of life.
Julian Beach, the interim executive director of healthcare quality and access at the Medicines and Healthcare Products Regulatory Agency (MHRA), highlighted the significance of the approval of Veoza (fezolinetant) for managing hot flushes and night sweats caused by menopause.
Acknowledging the commonality and impactful nature of these symptoms on women’s daily lives, Beach expressed the MHRA’s satisfaction in authorising Veoza through their reliance procedure, emphasising that rigorous safety, quality and effectiveness standards must be met for any approved medicine.
She said: “No medicine would be approved unless it met our expected standards of safety, quality and effectiveness, and we continue to keep the safety of all medicines under close review.”
Effective immediately, Veoza has been approved for use in women experiencing hot flushes associated with menopause.
However, the MHRA noted that the drug’s safety and efficacy have not been studied in women over the age of 65, leading to the absence of a recommended dosage for this age group.
Veoza will be available privately from January 5 as a prescription-only medicine. Astellas has initiated seeking approval from the National Institute for Health and Care Excellence (NICE) to facilitate access to Veoza through the National Health Service (NHS).
While the Department of Health and Social Care has yet to approve the price of Veoza, Astellas responded to inquiries about the treatment’s cost, revealing that in the United States, it is priced at $550 (£430) for a 30-day supply.
Veoza distinguishes itself as a non-hormonal menopause drug that directly targets the brain to prevent hot flushes.
Its unique mechanism of action involves blocking a brain protein called neurokinin-3, which plays a crucial role in regulating body temperature during menopause.
Marci English, the head of biopharma development at Astellas, praised the drug’s innovative approach, stating, “Fezolinetant’s novel mechanism of action targets the root cause of moderate to severe VMS [vasomotor symptoms] associated with menopause. We are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long.”
Experts, including Prof Waljit Dhillo of Imperial College London, foresee Veoza as a trans-formative and game-changing drug for women in the UK, particularly those for whom Hormone Replacement Therapy (HRT) is not suitable.
Dhillo emphasised the drug’s swift effectiveness, comparing it to a switch that eliminates hot flushes within a day or two.
Results from a large clinical trial of fezolinetant, published in March, demonstrated a substantial reduction in the frequency of hot flushes by approximately 60 per cent after 12 weeks of use, compared to a 45 per cent reduction in the placebo group.
Women also reported improvements in the severity of hot flushes and the quality of their sleep.
However, it is essential to note that while Veoza addresses hot flushes directly related to the temperature control pathway, it does not replace declining oestrogen levels in menopause and does not address a broader range of symptoms such as fatigue, muscle weakness and mood swings.
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