Astellas' VEOZAH™ (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause

 VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause

TOKYO, May 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAH^TM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause¹ on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

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VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.^2,3 VMS are the most common symptoms of menopause for which women seek treatment.⁴ In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition.^5,6,7 VMS can have a disruptive impact on women's daily activities and overall quality of life.²

"Today's approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the U.S. who experience moderate to severe vasomotor symptoms during the menopausal transition," said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. "This therapy is based on our understanding of the biology behind hot flashes. I'm excited to know that patients will have the option to choose this nonhormonal treatment."

Before menopause, there is a balance between estrogens (hormones made by a woman's ovaries) and neurokinin B (NKB), a brain chemical. This balance regulates the body's temperature control center located in a specific area of the brain. 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.

"VEOZAH uses a novel mechanism of action to target the root cause of VMS due to menopause," said Marci English, Vice President and Head of BioPharma Development, Astellas. "FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas' commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women's health."

The approval is supported by results from the BRIGHT SKY™ program, 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 to severe VMS due to menopause. 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.

For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022 and the press release "Astellas Provides Update on Fezolinetant New Drug Application in U.S." issued on February 20, 2023.

About VEOZAH (fezolinetant)
VEOZAH (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VEOZAH is not a hormone. 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"). 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.

Important Safety Information
Who should not take VEOZAH?
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.

What should I tell my healthcare provider before taking VEOZAH?
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)

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 the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.

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 VEOZAH package insert. Northbrook, IL: Astellas Inc.

² Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47.

³ Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120.

⁴ Williams RE, Kalilani L, DiBenedetti DB, et al. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas. 2007;58:348-358.

⁵ Gold EB, Colvin A, Avis N, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006;96:1226-1235.

⁶ 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;21:924-932.

⁷ Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008;11:32-43.

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SOURCE Astellas Pharma