Astellas breaks new ground in menopause with Veozah

Astellas has become the first drugmaker to bring a drug in the neurokinin 3 (NK3) receptor antagonist class to the US market, after getting FDA approval of fezolinetant for a common and debilitating symptom of menopause.

The once-daily oral drug has been cleared under the Veozah brand name for moderate to severe vasomotor symptoms (commonly known as hot flashes) in menopausal women, becoming a non-hormonal alternative to conventional oestrogen replacement therapies.

Hormone replacement therapy (HRT) can be highly effective for treating hot flashes, but isn’t recommended in some women – for example, if they have a higher risk of stroke or heart attack or have some forms of cancer. That’s because it can increase the risk of blood clots or stimulate the growth of some cancer types.

VMS are reported by up to 80% of women at some point during menopause and is the leading cause for seeking medical attention during this phase of their lives. Around a third of women report severe VMS, which can last 10 years or more after the last menstrual period.

In clinical trials, fezolinetant was shown to significantly reduce the frequency and severity of VMS compared to placebo over periods of up to 52 weeks. It has also been filed for approval in the EU, Switzerland, and Australia.

Astellas has said it will launch Veozah at a price of $550 per month, which is around three times the price that the Institute for Clinical and Economic Review (ICER) said would be cost-effective in a report issued in January.

That suggested a fair price would be $2,000-$2,600 per year, and suggested there were still uncertainties about the magnitude of the benefit fezolinetant provides and its long-term safety.

The pharma company has great expectations for the new therapy, which has reached the market ahead of its closest rival Bayer, whose NK1,3 antagonist elinzanetant is in late-stage clinical development. Both drugs are thought to work by binding to and blocking the activities of NK receptors that play a role in the brain’s regulation of body temperature.

It used a priority review voucher to cut the FDA’s review time down to six months, in order to claim the longest possible lead time before the competitor could reach the market, but that attempt was scuppered by a three-month delay at the FDA, which said it needed more time to appraise the marketing application.

Astellas is currently pitching peak sales guidance of 300 billion yen ($2.2 billion) to 500 billion yen per year for Veozah, which could go a long way to ease the pain of patent losses to its blockbuster cancer therapy Xtandi (enzalutamide) – partnered with Pfizer – due to take place in 2026 in Europe and Japan, and 2027 in the US.

Astellas acquired fezolinetant as part of its 2017 takeover of Ogeda for €500 million (at the time equivalent to around $550 million) upfront, plus €300 million in potential milestones.