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The adverse event reporting information can be found by scrolling to the bottom of this page.

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

Efficacy and Safety banner

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 flow chart using pooled data
Study design flow chart using pooled data

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

Achieve fewer and less severe VMS episodes with VEOZA vs. placebo
Achieve fewer and less severe VMS episodes with VEOZA vs. placebo
Achieve fewer and less severe VMS episodes with VEOZA vs. placebo
Achieve fewer and less severe VMS episodes with VEOZA vs. placebo
VEOZA is an option you can offer your eligible patients impacted by VMS
VEOZA is an option you can offer your eligible patients impacted by VMS

Reduction in frequency of VMS episodes was sustained through the study period1,3–5

Patients taking VEOZA experienced a significant reduction in moderate to severe VMS frequency by Week 4 vs. placebo, which was sustained through 52 weeks1,3–5

Following the 12-week placebo-controlled treatment period, patients were enrolled into an extension period, those initially taking a placebo were switched to VEOZA while patients who were initiated on VEOZA continued their treatment.1–3

Mean change in the frequency of moderate to severe VMS data was collected each week for an additional 40 weeks. The data during the extension period was summarised descriptively, with no inferential testing, due to the absence of a placebo control.1-3

Reduction in frequency of VMS episodes was sustained through the study period
Reduction in frequency of VMS episodes was sustained through the study period

†Graph produced using the FAS.3,4

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

SKYLIGHT 1 & SKYLIGHT 2

TWO identical Phase 3 efficacy and safety studies that were randomised, placebo-controlled, double-blind for 12 weeks, followed by re-randomisation of women previously receiving placebo to VEOZA (women on VEOZA remained on VEOZA) for an additional 40 weeks of uncontrolled treatment3,4

SKYLIGHT 4

ONE Phase 3, 52-week, randomised, placebo-controlled, double-blind study evaluating safety6

Adverse reactions for VEOZA 45 mg

  • 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

For the full safety profile of VEOZA refer to the SmPC.

Adverse reactions observed during clinical studies and from spontaneous reporting.

Adverse reactions for VEOZA 45 mg
Adverse reactions for VEOZA 45 mg

† In clinical trials, elevations in ALT levels > 3 x ULN occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in AST levels > 3 x ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo.
Serious cases with elevations of ALT and/or AST (> 10 x ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) were reported post-marketing. In some cases, elevated liver function tests 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. Elevated liver function tests and/or symptoms suggestive of injury were generally reversible on discontinuation of therapy.

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 flow chart
SKYLIGHT 4 Study Design

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

Sign up for VEOZA updates and product information

*Hot flushes are also known as hot flashes.7
 

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, ULN: upper limit of normal, 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. 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. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Astellas Pharma Ltd. on 0800 783 5018.

MAT-GB-VEO-2024-00241. February 2025.