The move has been welcomed as a ‘terrific’ option for women who shouldn’t or don’t want to take MHT.
The TGA has approved Australia’s first non-hormonal treatment for moderate to severe menopausal hot flushes.
Fezolinetant (Veoza) is expected to be available for patients within weeks and the manufacturer says it is “assessing pathways” towards a PBS listing.
The approval was welcomed by University of Sydney Obstetrics and Gynaecology Professor Rodney Baber, who is also a past president of the International Menopause Society.
“I think it’s nice for us to have an alternative that is TGA approved which we can use to treat hot flushes,” he told Rheumatology Republic.
“But clinicians need to remember, it won’t be quite as effective [as MHT] and it doesn’t do anything else except alleviate the flushes.”
Professor Baber said he was expecting strong interest from doctors and patients in the drug. Up until now, he said, other drugs such as antidepressants, centrally acting agents like gabapentin and clonidine and, and oxybutynin have been used off-label for relieving hot flushes in patients who shouldn’t or don’t want to use MHT.
The TGA approval allows for fezolinetant to be used to treat moderate to severe vasomotor symptoms associated with menopause.
“It’s great, we’ve got something that’s new, it’s approved for treatment of hot flushes, it’s going to work about as well as the other non-hormonal treatments and not as well as hormones,” said Professor Baber.
“But for women who would prefer not to take hormones or who should not take hormones this is a terrific option.”
He said fezolinetant had been shown to have similar effects as other non-hormonal treatments – about 60% reduction in hot flushes compared to around 80% for MHT and about 30-40% for placebos.
“I think patients will come asking for it,” he said.
“Hormone therapy certainly will treat hot flushes better than anything else. But it’s also good for bone health, quality of life and sleep, and probably for cardiovascular health. And some would say for mental health. Of course, it’s got other risks, but every single intervention we have has a risk.”
Fezolinetant is a nonhormonal selective NK3 receptor antagonist that blocks neurokinin B (NKB) binding on kisspeptin/neurokinin B/dynorphin (KNDy) neurons to modulate neuronal activity in the thermoregulatory centre. Under the TGA approval it will be included in the Black Triangle Scheme for five years.
The drug is a single tablet taken every day. Professor Baber said patients could see relief from hot flushes within about a week of starting treatment.
He said side effects included gastrointestinal upset and abdominal pain, which were experienced by 4-5% of women during clinical trials. He said fezolinetant was excreted by the kidneys so should not be used in patients with severe renal impairment.
“If you have mild to moderate renal impairment, you can use it quite safely and you don’t have to adjust the dose,” he said.
The TGA also recommended that liver function tests be performed prior to treatment and repeated during the first three months of treatment.
Professor Baber said he hoped the company would seek PBS listing to make fezolinetant more affordable for Australian patients.
Fezolinetant was approved by the FDA and in the EU last year, and in Switzerland and the UK about three weeks ago.
A spokesperson for Astellas Australia (the manufacturer of Veoza) told RR that the medication would be available on private prescription, although the company was “currently assessing the pathways toward reimbursement on the PBS for Veoza”.
“Currently there is no stock of Veoza in Australia,” said the spokesperson.
“We are working though the logistics to receive and ensure supply across Australia, which we anticipate within a month.”
The spokesperson said the company was unable to confirm or estimate the monthly cost of the drug, however details were expected to be announced before the drug was released to the market.
She said that as fezolinetant was a first-in-class non-hormonal treatment, the company was encouraging GPs to seek feedback from their patients on their experience taking the drug and the impacts on both their symptoms and their quality of life.
Prescribing information for GPs is available here.
