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VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.1

VMS are also known as hot flushes and night sweats.2

Woman spraying VEOZA™ (fezolinetant) logo fire extinguisher in office. Redefine how you target VMS

VEOZA achieved statistically significant reductions from baseline in the frequency and severity of moderate to severe VMS vs. placebo1

The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week uncontrolled extension treatment period.1 The studies consisted of postmenopausal women with a minimum average of 7 moderate to severe VMS per day1

SKYLIGHT 1 & SKYLIGHT 2 Study Design

Coprimary Endpoints:1

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

Study design flow chart using pooled data3

Study design flowchart: 1022 women on placebo or fezolinetant to week 12, then fezolinetant only for 40 uncontrolled weeks
Study design flowchart: 1022 women on placebo or fezolinetant to week 12, then fezolinetant only for 40 uncontrolled weeks

Secondary Endpoints:3,4

  • Mean change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) total score from baseline to Week 12
  • Mean change in daily frequency and severity of moderate and severe VMS from baseline to each week to Week 12
  • Percentage reductions of at least 50% and 75% in frequency of moderate and severe VMS from baseline analysed each week to Week 12

Study Population:1

Participants in the study:

  • Had a mean age of ~54 years (range: ≥40 and ≤65 years)
  • Self-identified as Caucasian (81%), Black (17%), Asian (1%), Hispanic/Latina (24%) ethnicity
  • Included post-menopausal women defined as having amenorrhoea for ≥12 consecutive months (70.1%) or amenorrhoea for ≥6 months with FSH >40 IU/l (4.1%) or having had bilateral oophorectomy ≥6 weeks prior to the screening visit (16.1%)
  • Included post-menopausal women with one or more of the following: prior hormone replacement therapy (HRT) use (19.9%), prior oophorectomy (21.6%), or prior hysterectomy (32.1%)

Achieve fewer and less severe VMS episodes with VEOZA vs. placebo1

The studies demonstrated that VEOZA provides a clinically meaningful** reduction in the frequency of moderate to severe VMS, while also reducing the severity of symptoms vs. placebo1,3,4

FREQUENCY: Measured as a daily mean and analysed as weekly average.3,4

** Clinically meaningful was defined as ≥2 hot flushes over 24 hours.1

Bar chart showing the mean change from baseline in frequency of moderate to severe VMS over 24 hours at weeks 4 and 12
Bar chart showing the mean change from baseline in frequency of moderate to severe VMS over 24 hours at weeks 4 and 12
Bar chart showing the mean change from baseline in severity of moderate to severe VMS over 24 hours at weeks 4 and 12
Bar chart showing the mean change from baseline in severity of moderate to severe VMS over 24 hours at weeks 4 and 12
VEOZA may help your patients continue activity with less sweat and disruption

VEOZA may help your eligible patients to continue their day with less severe and less frequent VMS1-3

RELIEF THAT WORKS FAST and LASTS1

In 1 week, patients taking VEOZA experienced a reduction in the number of VMS episodes, which was sustained through 52 weeks2,3

Line graph of mean change in frequency of moderate to severe VMS from baseline to week 52 in Skylight 1 and 2 studies

†Graph produced using the FAS.3,4

STUDY DESIGN

Mean change in frequency of VMS each week from baseline to week 12 was a secondary endpoint and was not adjusted for multiplicity,2,3

Mean change in the frequency 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.3.4

Help reduce the number of VMS episodes within one week with VEOZA1

A statistically significant improvement vs. placebo in the frequency and severity of moderate-to-severe vasomotor symptoms was observed as early as week 1 after treatment onset in both SKYLIGHT 1 and SKYLIGHT 2

BLN: baseline.

VEOZA was studied for safety and tolerability for 1 year1,6

The safety of VEOZA was evaluated in three Phase 3 clinical studies with 2203 women receiving VEOZA1

Table of common adverse reactions and frequency: diarrhoea, abdominal pain, insomnia, and increased alanine aminotransferase
  • Across the Phase 3 studies, the most common adverse reactions with VEOZA were diarrhoea (3.2%) and insomnia (3.0%). The most frequent adverse reactions leading to dose discontinuation with VEOZA were ALT increased (0.3%) and insomnia (0.2%)1
  • There were no serious adverse reactions reported at an incidence greater than 1% across the total study population1
  • Four serious adverse reactions were reported. The most serious adverse reaction was an event of endometrial adenocarcinoma (0.1%)1
  • Drug-induced liver injury (DILI). Elevations in serum ALT/ AST at least 3 times ULN were observed in women treated with fezolinetant, including serious cases with increased total bilirubin and symptoms suggesting liver injury. Elevated LFTs and symptoms suggestive of liver injury were generally reversible on discontinuation of therapy.
    Serious cases with elevations of ALT and/or AST (> 10 x ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase were reported post-marketing. In some cases, elevated LFTs were associated with signs and symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite, and/or abdominal pain

For Full List of Adverse Events please refer to the SmPC.

Table of common adverse reactions and frequency: diarrhoea, abdominal pain, insomnia, and increased alanine aminotransferase

VEOZA was assessed for endometrial safety

SKYLIGHT 4 was a randomised, placebo-controlled, double-blind, 52-week Phase 3 safety study of VEOZA in postmenopausal women, aged ≥40 to ≤65 years, seeking treatment for VMS6

SKYLIGHT 4 Study Design

Primary Endpoints:6

  • Frequency and severity of treatment-emergent adverse events (TEAEs)
  • Percentage of participants with endometrial hyperplasia
  • Percentage of participants with endometrial malignancy

Study design flow chart:6

Study design flowchart: SKYLIGHT 4
Study design flowchart: SKYLIGHT 5

Participants in this study:6

  • Had a mean age of ~55 years (range: ≥41 and ≤65 years)
  •  Self-identified as Caucasian (79.9%), Black or Afro-Caribbean (17.2%), and Asian (1.6%)
  • The study population included menopausal women with 1 or more of the following: prior hysterectomy (18.6%) or prior oophorectomy (13.5%)

In the long-term safety data, VEOZA (SKYLIGHT 1, 2 and 4) was evaluated for tolerability and endometrial safety compared to placebo over 52 weeks1,6

Endometrial safety of VEOZA was assessed by transvaginal ultrasound and endometrial biopsies, 304 women had baseline and post-baseline endometrial biopsies during the 52 weeks of treatment.

  • 1 case of endometrial adenocarcinoma was observed1
  • Endometrial biopsy assessments did not identify an increased risk of endometrial hyperplasia or malignancy according to prespecified criteria for endometrial safety1
  • Transvaginal ultrasound did not reveal increased endometrial thickness1

Contraindications:1

  • Hypersensitivity to the active substance or to any of the excipients
  • Concomitant use of moderate or strong CYP1A2 inhibitors
  • Known or suspected pregnancy

Learn about VEOZA dosing and administration

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ALT: alanine aminotransferase, AST: aspartate aminotransferase, BLN: baseline, FAS: full analysis set, FSH: follicle stimulating hormone, HRT: hormone replacement therapy, IU: international unit, LS: least squares, SD: standard deviation, SE: standard error, TEAE: treatment-emergent adverse event, VMS: vasomotor symptoms.

 

REFERENCES: 1. VEOZA Summary of Product Characteristics. 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. 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. 4. 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. span style="font-weight: 700;">5. Shapiro C.M.M., Neal-Perry G, Stute P, et al. Poster presented at 2022 North American Menopause Society (NMS) Annual Meeting. October 12–15, 2022. Atlanta, GA. 6. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomised controlled trial. Obstet Gynecol 2023:141(4): 737–47. 7. Depypere H, Lademacher C, Siddiqui E, et al. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs 2021;30(7):681–94.

Adverse events should be reported. For Ireland, Healthcare professionals are asked to report any suspected adverse reactions via; HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, Email: irishdrugsafety@astellas.com.

MAT-IE-VEO-2025-00010 February 2025