Astellas is returning to the Super Bowl to help educate game viewers about VEOZAH and vasomotor symptoms (VMS), the most commonly reported menopause symptoms¹

The "Fewer Hot Flashes, More Not Flashes" ad features women experiencing common moderate to severe hot flash and night sweat moments that impact their daily lives

NORTHBROOK, Ill., Feb. 1, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that it will air a new version of its commercial for VEOZAH^® (fezolinetant) just before Super Bowl kickoff on Sunday, February 11, 2024. VEOZAH is a nonhormonal treatment option approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats, due to menopause.^1,2 The "Fewer Hot Flashes, More Not Flashes" TV spot is expected to reach millions of women in the U.S. tuning in who may be experiencing VMS due to menopause, as well as their partners, friends, and family.^3,4

Jill Jaroch, Senior Director, Women's Health, Astellas
"Approximately half of the audience are women, making the Super Bowl an incredible platform to showcase the different types of hot flash moments women in midlife may experience.⁴ At Astellas, we want all women to feel heard and their unique needs to be validated, which is why we are continuing to elevate this conversation. After all, nearly half of women in the U.S. going through menopause may experience moderate to severe VMS.³ We want to empower them to talk openly about their experiences and to have more informed discussions with their healthcare providers about VEOZAH."  

The TV spot showcases relatable hot flash moments, emphasizing that fewer interruptions from moderate to severe VMS due to menopause can be possible.² When women with VMS are not having a hot flash, that's a not flash. The ad, as part of a larger consumer campaign, aims to encourage women to speak up and seek appropriate treatment options with their healthcare providers.  

To find more information about moderate to severe VMS due to menopause and this nonhormonal treatment option, visit VEOZAH.com.  

About VEOZAH^® (fezolinetant) 
VEOZAH^® (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist approved in the U.S. for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.² VEOZAH is not a hormone.² VMS are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes").¹ VEOZAH 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 reduce the frequency and severity of moderate to severe VMS due to menopause.^1,2

About VMS due to Menopause 
VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.¹ In the U.S., nearly half of women going through menopause may experience moderate to severe VMS.³ VMS can have a disruptive impact on women's daily activities and overall quality of life.⁵

U.S. Important Safety Information
Do not use VEOZAH if you: 

• have cirrhosis. 
• have severe kidney problems or kidney failure. 
• are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure. 

Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you: 

• have liver disease or problems. 
• have kidney problems. 
• have any medical conditions that may become worse while you are using VEOZAH. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works. 

What are the possible side effects of VEOZAH?
VEOZAH can cause serious side effects, including: 

• increased liver blood test values. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test at month 3, month 6, and month 9 after you start taking VEOZAH. 

Call your healthcare provider right away if you have the following signs and symptoms of liver problems: 

• nausea 
• vomiting 
• yellowing of the eyes or skin (jaundice) 
• pain in the right upper stomach (abdomen) 

The most common side effects of VEOZAH include: 

• stomach (abdominal) pain 
• diarrhea 
• difficulty sleeping (insomnia) 
• back pain 
• hot flashes or hot flushes 

These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

Call your healthcare provider for medical advice about side effects. You may report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 

For more information, please see the full Prescribing Information and Patient Product Information for VEOZAH (fezolinetant). 

About Astellas 
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en. 

Cautionary Notes 
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. 

References 

¹ Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician's Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55.

² Veozah [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 

³ Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause 2014;21(9):924-32.

⁴ Men, Women and the Super Bowl: The Science Marketers Should Note, Martec Group. https://martecgroup.com/men-women-and-the-super-bowl-the-science-marketers-should-note/ 

⁵ English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes 2021;5(37):1-13. 

SOURCE ASTELLAS PHARMA INC.