Astellas Submits Fezolinetant New Drug Application to U.S. FDA

Published: Jun. 23, 2022 at 7:30 PM EDT

Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause

TOKYO, June 23, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration (FDA). Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

Astellas stands on the forefront of healthcare change to turn innovative science into value for...
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.)(PRNewswire)

"In the United States, 60% to 80% of individuals experience VMS during or after the menopausal transition, with limited nonhormonal treatment options," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The fezolinetant NDA submission to the U.S. FDA is an important step in our efforts to bring to patients a first-in-class, nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause."

The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™.

Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.

Astellas is reviewing the financial impacts of this submission for the fiscal year ending March 31, 2023.

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 VMS Associated with Menopause

VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life.1

About Fezolinetant

Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.3,4,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

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

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


2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014. Col 2, para 1, lines 4-6.


3 Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. Przegl Menopauzalny [Menopause Rev]. 2014;13:203-211.


4 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.


5 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.


6 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.


7 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderates levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225.

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