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Efficacy & Safety

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For the treatment of moderate to severe Vasomotor Symptoms (VMS)—commonly referred to as hot flashes and night sweats—due to menopause1,2

Woman spraying VEOZAHTM (fezolinetant) logo fire extinguisher at VMS fire in bedroom

READY, AIM, REDUCE

Based on coprimary endpoint data below.

VEOZAH achieved clinically meaningful VMS reductions and was evaluated for safety in 1100 women for up to a year1*

The efficacy of VEOZAH was studied in 1022 women who received 1 of 2 doses of VEOZAH (including 45 mg) in two 12-week, randomized, placebo-controlled, double-blind Phase 3 studies. In each of these 2 trials, after the first 12 weeks, women on placebo were rerandomized to VEOZAH for a 40-week extension to evaluate safety for up to 52 weeks total exposure.1

Study population

Select inclusion criteria1,2:
  • Born female, aged ≥40 to ≤65 years, with moderate to severe VMS due to menopause (minimum average of 7 moderate to severe VMS episodes per day or 50 to 60 per week) and confirmed menopausal

    Menopause was defined as: spontaneous amenorrhea for ≥12 consecutive months, spontaneous amenorrhea for ≥6 months with biochemical criteria of menopause (follicle-stimulating hormone >40 IU/L), or bilateral oophorectomy ≥6 weeks before the screening visit (with or without hysterectomy)

  • Body mass index >18 kg/m2 and ≤38 kg/m2
Select exclusion criteria1-4:
  • History of undiagnosed uterine bleeding within the last 6 months
  • Unacceptable result from the transvaginal ultrasound assessment at screening
  • Endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant findings at screening
Participants in the study5:
  • Self-identified as Caucasian (81%), African American (17%), Asian (1%), Hispanic/Latina ethnicity (24%). The mean age was 54 years
  • Included menopausal women with prior hormone therapy use (19.9%), with oophorectomy (21.6%), or with hysterectomy (32.1%)

REFERENCES: 1. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet (Epub) 03-13-2023. 2. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab (Epub) 02-03-2023.
3. ClinicalTrials.gov. A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause (Skylight 1) (08-12-2022). https://clinicaltrials.gov/ct2/show/NCT04003155. Accessed 08-15-2022. 4. ClinicalTrials.gov. A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause - 2 (Skylight 2) (07-18-2022). https://clinicaltrials.gov/ct2/show/NCT04003142. Accessed 08-15-2022. 5. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

COPRIMARY ENDPOINTS1:

Mean change from baseline in moderate to severe VMS frequency and severity to weeks 4 and 12

SELECT SECONDARY ENDPOINTS3-6:

Mean percent reduction in the frequency of moderate to severe VMS from baseline to week 12

Mean change in the frequency and severity of moderate to severe VMS from baseline to each week up to week 12

With VEOZAH, achieve statistically significantly fewer and less intense VMS1

Help patients reduce VMS frequency and severity

MEAN CHANGE FROM BASELINE IN MODERATE TO SEVERE VMS

OVER 24 HOURS1,7

Trial 1 with 174 women taking VEOZAH 45 mg and 175 women taking placebo
Trial 2 with 167 women taking VEOZAH 45 mg and 167 women taking placebo
Bar chart showing the mean change in frequency from baseline of moderate to severe VMS over 24 hours at week 4
Hot flashes cut in half by week 4 vs ~one-third with placebo
Bar chart showing the mean change in frequency from baseline of moderate to severe VMS over 24 hours at week 12
63% fewer hot flashes by week 12 vs 42% with placebo
Trial 1 with 174 women taking VEOZAH 45 mg and 175 women taking placebo
Trial 2 with 167 women taking VEOZAH 45 mg and 167 women taking placebo
Bar chart showing the mean change in frequency from baseline of moderate to severe VMS over 24 hours at week 4
Bar chart showing the mean change in frequency from baseline of moderate to severe VMS over 24 hours at week 12
Hot flashes cut in half by week 4 vs ~one-third with placebo
63% fewer hot flashes by week 12 vs 42% with placebo
FREQUENCY: Measured as a daily mean and analyzed as weekly average.3,4

LS mean: Least squares mean estimated from a mixed model for repeated measures analysis of covariance.1

Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.1

*Clinically meaningful is defined as a reduction in ≥2 hot flashes per day versus placebo.1

Day and night icon

With VEOZAH, help your patients reduce VMS interruptions day and night

MEAN CHANGE FROM BASELINE IN MODERATE TO SEVERE VMS

OVER 24 HOURS1

Trial 1 with 174 women taking VEOZAH 45 mg and 175 women taking placebo
Trial 2 with 167 women taking VEOZAH 45 mg and 167 women taking placebo
Bar chart showing the mean change in severity from baseline of moderate to severe VMS over 24 hours at week 4
Bar chart showing the mean change in severity from baseline of moderate to severe VMS over 24 hours at week 12
Reduced, on average, from moderate/severe to mild/moderate
Trial 1 with 174 women taking VEOZAH 45 mg and 175 women taking placebo
Trial 2 with 167 women taking VEOZAH 45 mg and 167 women taking placebo
Bar chart showing the mean change in frequency from baseline of moderate to severe VMS over 24 hours at week 4
Bar chart showing the mean change in severity from baseline of moderate to severe VMS over 24 hours at week 12
Reduced, on average, from moderate/severe to mild/moderate
SEVERITY: Scored as a daily mean and analyzed as a weekly average3,5,6:

3=SEVERE
Sensation of heat with sweating causing disruption to activity

2=MODERATE
Sensation of heat with sweating, able to continue activity

1=MILD
Sensation of heat without sweating

LS mean: Least squares mean estimated from a mixed model for repeated measures analysis of covariance.1

Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.1

Woman sweating icon

VEOZAH allows you to help your patients continue activity with less sweat and disruption

Relief that works fast and lasts3,4

The effect of VEOZAH on VMS frequency and severity was evident by week 1.† There was no evidence of loss of effect through 52 weeks3,4‡

CHANGE IN MODERATE TO SEVERE VMS

UP TO WEEK 523,4,7

Trial 1 with 174 women taking VEOZAH 45 mg, 175 women taking placebo, and 76 women rerandomized to taking VEOZAH 45 mg
Trial 2 with 167 women taking VEOZAH 45 mg, 167 women taking placebo, and 75 women rerandomized to taking VEOZAH 45 mg
Line graph showing the mean reduction in frequency of moderate to severe VMS from baseline up to week 52
Trial 1 with 174 women taking VEOZAH 45 mg, 175 women taking placebo, and 76 women rerandomized to taking VEOZAH 45 mg
Trial 2 with 167 women taking VEOZAH 45 mg, 167 women taking placebo, and 75 women rerandomized to taking VEOZAH 45 mg
Line graph showing the mean reduction in frequency of moderate to severe VMS from baseline up to week 52

†Mean change in frequency and severity of VMS from baseline to each week up to week 12 were secondary endpoints and were not adjusted for multiplicity.3,4

‡Mean change in the frequency and severity of VMS from baseline to each visit in the extension period was an exploratory endpoint. Assessments after the 12-week placebo-controlled period were descriptive only.3,7

BLN=baseline.

CHANGE IN MODERATE TO SEVERE VMS

UP TO WEEK 523,4,7

Trial 1 with 174 women taking VEOZAH 45 mg, 175 women taking placebo, and 76 women rerandomized to taking VEOZAH 45 mg
Trial 2 with 167 women taking VEOZAH 45 mg, 167 women taking placebo, and 75 women rerandomized to taking VEOZAH 45 mg
Line graph showing the mean reduction in severity of moderate to severe VMS from baseline up to week 52
Trial 1 with 174 women taking VEOZAH 45 mg, 175 women taking placebo, and 76 women rerandomized to taking VEOZAH 45 mg
Trial 2 with 167 women taking VEOZAH 45 mg, 167 women taking placebo, and 75 women rerandomized to taking VEOZAH 45 mg
Line graph showing the mean reduction in severity of moderate to severe VMS from baseline up to week 52

BLN=baseline (2.4).

†Mean change in frequency and severity of VMS from baseline to each week up to week 12 were secondary endpoints and were not adjusted for multiplicity.3,4

‡Mean change in the frequency and severity of VMS from baseline to each visit in the extension period was an exploratory endpoint. Assessments after the 12-week placebo-controlled period were descriptive only.3,7

VEOZAH was studied for safety and tolerability for 1 year1

The safety of VEOZAH was evaluated in three 52-week clinical trials with 1100 women receiving VEOZAH1

Study designs

TRIALS 1&2

TWO identical Phase 3 efficacy and safety studies that were randomized, placebo-controlled, double-blind for 12 weeks, followed by rerandomization of women previously receiving placebo to VEOZAH (women on VEOZAH remained on VEOZAH) for an additional 40 weeks of uncontrolled treatment.1

TRIAL 3

ONE Phase 3, 52-week, randomized, placebo-controlled, double-blind study evaluating safety.1

REFERENCE: 1. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

ADVERSE EVENTS IN TRIAL 3

(≥2% in VEOZAH 45 mg and > placebo)1*
ADVERSE REACTION VEOZAH 45 mg (n=609)   Total person-years=504.2 n (%, EAIR) PLACEBO (n=610)
Total Person-Years=475.0 n (%, EAIR)
Abdominal pain†26 (4.3%, 5.2)13 (2.1%, 2.7)
Diarrhea24 (3.9%, 4.8)16 (2.6%, 3.4)
Insomnia24 (3.9%, 4.8)11 (1.8%, 2.3)
Back pain18 (3.0%, 3.6) 13 (2.1%, 2.7)
Hot flush15 (2.5%, 3.0)10 (1.6%, 2.1)
Hepatic transaminase elevation‡14 (2.3%, 2.8) 5 (0.8%, 1.1)

EAIR=exposure-adjusted incidence rate.

*Measured as EAIR, meaning the number of individuals experiencing an adverse event divided by exposure time (total person-years) x 100.1

†Abdominal pain (including abdominal pain, abdominal pain lower, abdominal pain upper).1

‡Hepatic transaminase elevations (including alanine aminotransferase [ALT] abnormal, ALT increased, aspartate aminotransferase [AST] abnormal, AST increased).1

In the pooled laboratory data of Trials 1, 2, and 3, elevated hepatic transaminases (>3x the ULN) occurred in 25 women (2.3%, 2.7 EAIR) exposed to VEOZAH 45 mg (n=1100, 912.1 total person-years) as compared to 8 women (0.9%, 1.5 EAIR) exposed to placebo (n=952, 549.1 total person-years).1

VEOZAH was assessed for liver and endometrial safety

Liver icon
  • Across the Phase 3 trials, elevations in serum ALT and/or AST >3x the ULN occurred in 2.3% of patients receiving VEOZAH (EAIR of 2.7 per 100 person-years) and 0.9% (EAIR of 1.5 per 100 person-years) of patients receiving placebo
  • No serum elevations in total bilirubin (>2x the ULN) occurred
  • Women with ALT or AST elevations were generally asymptomatic
  • Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation
  • Women with cirrhosis were not studied

ULN=upper limit of normal.

Endometrial safety icon

In patients receiving VEOZAH 45 mg across the Phase 3 studies,

  • Endometrial biopsy assessments identified 1 case of endometrial hyperplasia and 1 case of endometrial malignancy
  • The rate of these events was ≤1%, with the upper bound of the one-sided 95% confidence limit being ≤4%
  • Disordered proliferative endometrium was reported in 5 patients receiving VEOZAH 45 mg (EAIR of 1.4 per 100 person-years) and 4 patients receiving placebo (EAIR of 2.0 per 100 person-years)
Woman holding fire extinguisher
Woman holding fire extinguisher

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. Concomitant use with CYP1A2 inhibitors

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

INDICATIONS AND USAGE

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. Concomitant use with CYP1A2 inhibitors

WARNINGS AND PRECAUTIONS

Hepatic Transaminase Elevation

Elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x the upper limit of normal (ULN) occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo in three clinical trials. No serum elevations in total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied.

Perform baseline bloodwork to evaluate for hepatic function and injury prior to VEOZAH initiation. Do not start VEOZAH if concentration of ALT or AST is ≥ 2x ULN or if the total bilirubin is elevated (e.g., ≥ 2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is < 2x ULN and the total bilirubin is normal, VEOZAH can be started. Perform follow-up evaluations of hepatic transaminase concentration at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms (such as nausea, vomiting, or yellowing of the skin or eyes) suggest liver injury.

ADVERSE REACTIONS

The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%).

Please click here for full Prescribing Information for VEOZAH™ (fezolinetant).

REFERENCES: 1. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. 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. 3. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet (Epub) 03-13-2023. 4. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab (Epub) 02-03-2023. 5. ClinicalTrials.gov. A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause (Skylight 1) (08-12-2022). https://clinicaltrials.gov/ct2/show/NCT04003155. Accessed 08-15-2022. 6. ClinicalTrials.gov. A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause - 2 (Skylight 2) (07-18-2022). https://clinicaltrials.gov/ct2/show/NCT04003142. Accessed 08-15-2022. 7. Astellas. VEOZAH. Data on File.