The results will be featured in an oral presentation
SKYLIGHT 4 results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolinetant-treated patients; reported treatment-emergent adverse events (TEAEs) were generally mild or moderate in severity and headache and COVID-19 were the most common TEAEs, with similar incidences for fezolinetant and placebo. The frequency of elevated liver enzymes was low across groups, and elevations were generally asymptomatic, isolated, transient and resolved on treatment or soon after study drug discontinuation.
'There is an unmet need for safe and effective nonhormonal treatment options for VMS associated with menopause, which can adversely impact daily quality of life,' said
In addition, pooled efficacy data from SKYLIGHT 1 and SKYLIGHT 2 evaluating early response to fezolinetant, its impact on sleep and treatment response analyzed by race will be presented.
'Results of the SKYLIGHT 4 study and the pooled analyses from the SKYLIGHT 1 and 2 studies provide further insights into the safety and effectiveness of fezolinetant,' said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 'Through our clinical development program, we are excited to further characterize the clinical profile of fezolinetant for women who experience hot flashes as part of menopause.'
Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist and is not approved for use anywhere in the world. New Drug and Marketing Authorization applications for fezolinetant are under review in the
Astellas will also present three abstracts examining the association between VMS and weight gain, sleep quality and work productivity.
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
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
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.7,8,9 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
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.
Contact:
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Email: anna.otten@astellas.com
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