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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 VEOZAH™ (fezolinetant) logo fire extinguisher at VMS fire in bedroom

READY, AIM, REDUCE

Based on coprimary endpoint data below.

VEOZAH achieved clinically meaningful VMS reductions1*

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

Eligibility criteria

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 2023;401(10382):1091-102. 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 ENDPOINTS3-7:
  • Mean change in the PROMIS SD SF 8b total score from baseline to week 12 (key secondary endpoint)
  • Mean percent reduction in the frequency of moderate to severe VMS from baseline to each week up to week 12
  • Mean change in the frequency and severity of moderate to severe VMS from baseline to each week up to week 12

PROMIS SD SF 8b=Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b.

*Clinically meaningful is defined as a reduction in ≥2 hot flashes per 24 hours versus placebo.1

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
TRIAL 2
VEOZAH 45 mg (n=174)
Placebo (n=175)
VEOZAH 45 mg (n=167)
Placebo (n=167)
HOT FLASHES CUT IN HALF

by week 4 vs ~one-third with placebo†

61% FEWER HOT FLASHES

by week 12 vs 35% with placebo†

HOT FLASHES CUT IN HALF

by week 4 vs ~one-third with placebo†

64% FEWER HOT FLASHES

by week 12 vs 45% with placebo†

Day and night icon

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

FREQUENCY: Measured as a daily mean and analyzed as a 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

†Percent change from baseline was a secondary endpoint.5,6

MEAN CHANGE FROM BASELINE IN MODERATE TO SEVERE VMS
OVER 24 HOURS1,3,4

TRIAL 1
TRIAL 2
VEOZAH 45 mg (n=174)
Placebo (n=175)
VEOZAH 45 mg (n=167)
Placebo (n=167)
REDUCED, ON AVERAGE, FROM

moderate/severe  mild/moderate

REDUCED, ON AVERAGE, FROM

moderate/severe  mild/moderate

Woman sweating icon

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

SEVERITY: Scored as a daily mean and analyzed as a weekly average3,4:

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

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 523,4,7,8

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
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
Line graph showing the mean reduction in frequency of moderate to severe VMS from baseline up to week 52

BLN=baseline.

*Mean change in frequency and severity of VMS from baseline to each week up to week 12 were secondary endpoints and were descriptive only.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.4,7

CHANGE IN MODERATE TO SEVERE VMS
UP TO WEEK 523,4,7,8

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
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
Line graph showing the mean reduction in severity of moderate to severe VMS from baseline up to week 52

BLN=baseline.

*Mean change in frequency and severity of VMS from baseline to each week up to week 12 were secondary endpoints and were descriptive only.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.4,7

Crescent moon icon
Crescent moon icon

In one study, hot flashes negatively impacted sleep for 82% of women who reported at least moderate VMS9*

VMS can be associated with sleep disturbance9

test

*From the Menopause Epidemiology (MEPI) Study of postmenopausal women 40 to 65 years old; N=1542 experiencing at least moderate Vasomotor Symptoms due to menopause were included in the sleep impact model.9

Select patient-reported outcomes

Change in patient-reported sleep disturbance

PROMIS SLEEP DISTURBANCE SHORT FORM 8b (PROMIS SD SF 8b)

MEAN CHANGE FROM BASELINE TO WEEK 12 IN TOTAL SCORE4,7

PROMIS SD SF 8b assessed self-reported sleep disturbance over the past 7 days. The total score included perceptions of3,4,10:

  • Restless sleep
  • Satisfaction with sleep
  • Refreshing sleep
  • Difficulties sleeping
  • Difficulties getting to sleep
  • Difficulties staying asleep
  • Amount of sleep
  • Sleep quality

The mean change in the PROMIS SD SF 8b total score from baseline to week 12 is a key secondary endpoint. At the individual trial level, P values were adjusted for multiplicity to control for type 1 error.3,4,7

*In Trial 1, the observed improvement in PROMIS SD SF 8b for VEOZAH 45 mg vs placebo was not statistically significant at week 12.3

†In Trial 2, results were statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.4

Total score in PROMIS SD SF 8b was calculated by summing the items (range: 8-40), with a higher score meaning more disturbed sleep. A negative change in the PROMIS SD SF 8b total score indicated a reduction/improvement from baseline (ie, favorable outcome).3,4,7

LS=least squares, MMRM=mixed models for repeated measures, PROMIS=Patient-Reported Outcomes Measurement Information System.

PROMIS SLEEP DISTURBANCE SHORT FORM 8b (PROMIS SD SF 8b)

MEAN CHANGE FROM BASELINE TO WEEK 12 IN TOTAL SCORE4,7,11

PROMIS SD SF 8b assessed self-reported sleep disturbance over the past 7 days. The total score included perceptions of3,4,10:

  • Restless sleep
  • Satisfaction with sleep
  • Refreshing sleep
  • Difficulties sleeping
  • Difficulties getting to sleep
  • Difficulties staying asleep
  • Amount of sleep
  • Sleep quality

The mean change in the PROMIS SD SF 8b total score from baseline to week 12 is a key secondary endpoint. At the individual trial level, P values were adjusted for multiplicity to control for type 1 error.3,4,7

*The pooled data come from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% confidence intervals are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of pooled analysis.7,11

Total score in PROMIS SD SF 8b was calculated by summing the items (range: 8-40), with a higher score meaning more disturbed sleep. A negative change in the PROMIS SD SF 8b total score indicated a reduction/improvement from baseline (ie, favorable outcome).3,4,7

LS=least squares, MMRM=mixed models for repeated measures, PROMIS=Patient-Reported Outcomes Measurement Information System.

Woman holding fire extinguisher with smoke behind her
Woman holding fire extinguisher with smoke behind her

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

EXPAND COLLAPSE

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

WARNING: RISKS OF HEPATOTOXICITY

Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.

  • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
  • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
  • Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
  • Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN.
  • If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

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

WARNING: RISKS OF HEPATOTOXICITY

Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.

  • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
  • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
  • Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
  • Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN.
  • If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.
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

Hepatotoxicity

In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x ULN occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo. No elevations in serum 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.

In the postmarketing setting, cases of drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin occurred within 40 days of starting VEOZAH. Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine. The patients’ signs and symptoms gradually resolved after discontinuation of VEOZAH.

Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if ALT or AST is ≥ 2x ULN or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.

Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.

See BOXED WARNING for full hepatic laboratory testing protocol and discontinuation criteria. Exclude alternative causes of hepatic laboratory test elevations.

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, including BOXED WARNING, 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 2023;401(10382):1091-102. 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. 8. Supplement to: 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 2023;401(10382):1091-102. 9. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas 2009;62(2):153-9. 10. Schultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause. Health Qual Life Out (Epub) 11-21-2023. 11. Shapiro MCM, Cano A, Nappi RE, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. [Published online May 15, 2024]. Maturitas. 2024.