A “game-changing” drug that prevents hot flashes and could benefit hundreds of thousands of women has been approved for use in the UK.
The green light for Veoza, also known as fezolinetant, comes after the US regulator, the Food and Drug Administration, authorized it for use in America in May.
Hot flashes, also called vasomotor symptoms, affect about 70% of women going through menopause. Women can feel suddenly and overwhelmingly hot, often impacting their quality of life, exercise, sleep and productivity.
Despite the enormous number of women affected, for decades there were few safe and effective treatment options. Hormone replacement therapy (HRT) is the most effective, but it is unsuitable for many, such as some women with a history of breast or ovarian cancer, blood clots or with untreated high blood pressure. Some women experience side effects or prefer a non-hormonal alternative.
Speaking to the Guardian on Sunday, Julian Beach, the interim executive director of healthcare quality and access at the Medicines and Healthcare Products Regulatory Agency (MHRA), said: “Hot flashes and night sweats caused by menopause are common and can have a significant impact on a woman’s daily life So we are pleased to have authorized Veoza (fezolinetant) for hot flashes and night sweats caused by menopause via our dependency procedure.
“No medicine will be approved unless it meets our expected standards of safety, quality and efficacy, and we continue to scrutinize the safety of all medicines.”
Veoza is approved for use in women experiencing hot flashes associated with menopause with immediate effect. However, it has not been studied for safety and effectiveness in women over 65, the MHRA said, so no dosage recommendation can yet be made for this age group.
The drug is a prescription-only medicine and will initially be available privately starting Jan. 5, according to officials at Astellas, which manufactures the drug. The company has started the process of applying to the National Institute for Health and Care Excellence to enable women to access the treatment on the NHS.
The price of Veoza has not yet been approved by the Department of Health and Social Care, Astellas said in response to questions about the cost of the treatment. In the US, the cost is set at $550 (£430) for a 30-day supply.
Veoza is a non-hormonal menopause drug that acts directly on the brain to prevent hot flashes. It works by blocking a brain protein called neurokinin-3 that plays a unique role in regulating body temperature in menopausal women.
Marci English, Head of Biopharma Development at Astellas, said: “Fezolinetant’s new 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 progress for too long.”
Experts spoke earlier this year after its approval in the US, said the treatment can be transformative for hundreds of thousands of women in the UK for whom HRT is not suitable.
“This is going to be an absolutely giant drug,” says Prof Waljit Dhillo, an endocrinologist at Imperial College London who led a pioneering trial in 2017 that paved the way for the drug’s development. “It’s like a switch. Within a day or two the flushes go away. It’s amazing how well these remedies work. It’s going to be a complete game-changer for many women.”
A large clinical trial of fezolinetant published in March showed that after 12 weeks of use it reduced the frequency of hot flashes by around 60% in women with moderate or severe symptoms, compared with a 45% reduction in those who received a placebo. Women also reported that the drug reduced the severity of hot flashes and improved the quality of their sleep.
Veoza works directly on the temperature control pathway and does not replace estrogen, which drops steeply in menopause. The treatment will not address the wider range of symptoms that some women experience, including fatigue, muscle weakness and mood swings.
Diane Danzebrink, a menopause campaigner, said: “Hot flashes and night sweats are common menopause symptoms that can be debilitating, affecting personal health and wellbeing, family life and careers. It’s welcome news that doctors will have an alternative option to consider during a consultation, according to individual suitability. The decision is particularly important for those who have felt overlooked in terms of treatment options in the past, or those who choose not to use HRT.”
