Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VMS is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

VMS are the most common symptoms of menopause for which women seek treatment. In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition. VMS can have a disruptive impact on women's daily activities and overall quality of life.

As the body goes through menopause, estrogens decline and this balance is disrupted. This imbalance can lead to very uncomfortable symptoms called VMS. VEOZAH helps to restore the balance by blocking NKB in the temperature control center to reduce the number and intensity of hot flashes. The approval is supported by results from the BRIGHT SKY™?

progr am, which included three Phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 individuals across the U.S., Canada and Europe. Results from the SKYLIGHT 1™? and SKYLIGHT 2™?

pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate tosevere VMS due to menopase. Data from the SKYLIGHT 4™? safety study further characterizes the long-term safety profile of fezolinetant.

Marketing authorization applications for fezolinetant are also under regulatory review in the EU, Switzerland and Australia. Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2024.