The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of fezolinetant – manufactured under the brand name of Veoza – to treat hot flushes and night sweats associated with the menopause.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said the organisation was pleased to approve the medicine via its reliance procedure as ‘hot flushes and night sweats caused by menopause are common, and can have a significant impact on a woman’s daily life’.
He added: ‘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.’
The British Menopause Society (BMS) issued a statement saying it was ‘delighted’ with the news.
Haitham Hamoda, consultant gynaecologist and BMS trustee, said: ‘Hot flushes and night sweats, often referred to as vasomotor symptoms (VMS), are the most common symptoms of the menopause.
‘Having access to fezolinetant, a new non-hormonal treatment option, will increase the options available to women, in particular those who can’t take HRT or do not wish to take it.’
Mr Hamoda added that the availability of the drug could offer many women experiencing VMS ‘considerable improvement’ in their day-to-day life.
‘Vasomotor symptoms (VMS) can have a significant impact on many women, with more than 75% experiencing VMS and a quarter describing their symptoms as severe,’ he said.
‘A third of women experience long-term symptoms, which may last as much as seven years or longer.’
The authorisation by the MHRA follows approval for fezolinetant being granted by the European Commission (EC) earlier this month, applicable in all EC member states as well as Iceland, Norway and Liechtenstein, while Switzerland has also approved the drug.
Veoza is manufactured by Astellas Pharma Inc, headquartered in Tokyo, Japan.
According to Marci English, head of biopharma development at the company, fezolinetant’s novel mechanism of action targets the ‘root cause’ of moderate to severe VMS associated with menopause.
‘We are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long,’ she said.