Tokyo-based Astellas Pharma has won FDA approval for Veozah (fezolinetant) 45 mg to treat moderate to severe vasomotor symptoms associated with menopause. The non-hormonal menopause treatment represents the first neurokinin 3 receptor antagonist to win FDA backing for vasomotor symptoms, which afflict 60-80% of women during menopause.

The approval was based on the BRIGHT SKY program, which included three phase 3 trials enrolling more than 3,000 women. The studies demonstrated Veozah reduced hot flash frequency and severity.

Fezolinetant is a neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain—the hypothalamus—to curb the frequency and severity of moderate to severe VMS.

In a statement, Astellas noted that marketing applications are under review in the European Union, Switzerland and Australia. The company has updated its 2024 projections based on the regulatory win.

According to one analyst report, the global menopause treatment market is worth roughly $13.3 billion, and could hit $22.9 billion by 2032.

The menopause treatment landscape has evolved considerably over the years. Initially, hormone replacement therapy (HRT) was the mainstay of treatment for hot flashes and other menopause symptoms. HRT has steadily lost market share, however, due to concerns related to an increased risk of breast cancer, heart disease and stroke.

Consequently, several non-hormonal treatments hit the market. Off-label treatments that have found use include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and gabapentin. Such therapies, however, are generally less effective than HRT and can also have side effects such as nausea, dry mouth and weight gain.

In 2013, the FDA approved Brisdelle, the first non-hormonal treatment specifically for hot flashes. Brisdelle contains paroxetine, a type of SSRI. Paroxetine can also have side effects similar to other SSRIs, such as sleep problems, dry mouth and nausea, and can interact with numerous other medications.

Ultimately, the approval of Veozah could represent a new chapter in the treatment of hot flashes. As the first non-hormonal NK3 receptor antagonist, it offers a new mechanism of action to reduce the frequency and severity of hot flashes. In addition, the safety and efficacy data from the BRIGHT SKY program suggest that Veozah has the potential to improve the quality of life for millions of women.