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

3 women in bathrobs are sitting on the beach looking out over the sea. VEOZA™ (fezolinetant) can give clinical meaningful relief

VEOZA achieved statistically significant reductions from baseline in the frequency and severity of moderate to severe VMS vs. placebo.2

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 non-placebo controlled extension treatment period.2 The studies consisted of postmenopausal women with a minimum average of 7 moderate to severe VMS per day2

SKYLIGHT 1 & SKYLIGHT 2 Study Design2-4

Coprimary endpoints:

Mean change from baseline in moderate to severe VMS frequency and severity2-4

Secondary Endpoints:2-4

  • 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

Participants in the study:2-4

  • Had a mean age of ~54 years (range: ≥40 and ≤65 years)*
  • Self-identified as Caucasian (81%), African American (17%), Asian (1%), Hispanic/Latina ethnicity (24%)*
  • Included menopausal women with prior hormone therapy use (19.9%), with oophorectomy (21.6%), or with hysterectomy (32.1%)*

*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to 45 mg dose

Achieve fewer and less severe VMS episodes with VEOZA vs. placebo2

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. placebo at week 4 & 12.2

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
Infographic showing roughly 2 of 3 moderate to severe VMS eliminated at week 12 (63%) and severity reduction from 2.4 to 2.0
Infographic showing roughly 2 of 3 moderate to severe VMS eliminated at week 12 (63%) and severity reduction from 2.4 to 2.0

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

FREQUENCY: Measured as a daily mean and analyzed as weekly average2-4

Reduction in frequency of VMS episodes was sustained through the study period.3,4

Patients taking VEOZA experienced a significant reduction in moderate to severe VMS frequency by Week 4 and 12 vs. placebo, which was sustained through 52 weeks.3,4 

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.

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.3,4

Line graph of mean change in frequency of moderate to severe VMS from baseline to week 52 in Skylight 1 and 2 studies
Line graph of mean change in frequency of moderate to severe VMS from baseline to week 52 in Skylight 1 and 2 studies
Now there´s VEOZA, with results that can reduce your patinets hot flushes and night sweats

Now there’s VEOZA, with results that can reduce your patients’ hot flushes and night sweats2-4

VEOZA was studied for safety and tolerability

The safety of VEOZA was evaluated in phase 3 clinical studies with 2 203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice5

  • Across the phase 3 studies, the most common adverse reactions (≥3%) with VEOZA 45 mg were diarrhoea (3.2%) and insomnia (3.0%)5

Legend: Common (≥ 1/100 to < 1/10); Not known (cannot be estimated from the available data).

* SmPC see section 4.8

  • The most frequent adverse reactions leading to dose discontinuation with VEOZA in the Phase 3 trials were an ALT increase (0.3%) and insomnia (0.2%)5
  • In the clinical trials there were no SAEs at an incidence >1% across the total study population.
    On VEOZA, 4 SAEs were reported, the most common SAE being endometrial adenocarcinoma (0.1%).5

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 VMS.6

Study design6

Primary endpoints:6

  • Frequency and severity of treatment-emergent adverse events (TEAEs)
  • Percentage of participants with endometrial hyperplasia
  • Percentage of participants with endometrial malignancy
Infographic showing roughly 2 of 3 moderate to severe VMS eliminated at week 12 (63%) and severity reduction from 2.4 to 2.0

Study population6

  • Self-identified as Caucasian (80%), Black (17%), Asian (2%), Hispanic/Latina ethnicity (20%)*
  • The mean age was ~55 years*
  • Included menopausal women with prior hormone therapy use (17.0%), with oophorectomy (13.5%), or with hysterectomy (18.6%)*

*Baseline demographics include women receiving fezolinetant 30 mg

In the long-term safety data (SKYLIGHT 1, 2 and 4), endometrial safety of VEOZA was assessed by transvaginal ultrasound and endometrial biopsies (304 postmenopausal women had baseline and post-baseline endometrial biopsies during 52 weeks of treatment)2

  • 1 case of endometrial adenocarcinoma was observed5
  • Endometrial biopsy assessments did not identify an increased risk of endometrial hyperplasia or malignancy according to prespecified criteria for endometrial safety2
  • Transvaginal ultrasound did not reveal increased endometrial thickness2

VEOZA dosing and administration

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*See section 5.1 in SmPC


VMS=vasomotor symptoms


REFERENCES: 1. VEOZA SmPC §4.1 02.2025. 2. VEOZA SmPC §5.1 02.2025. 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. 2023;108(8):1981-1997. 5. VEOZA SmPC §4.8 02.2025. 6. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstet Gynecol. 2023;141(4):737-47.

VEOZA™ (fezolinetant), 45 mg filmdragerade tabletter, G02CX06, Rx, (F)

 

▼Detta läkemedel är föremål för utökad övervakning.

Indikation: Behandling av måttliga till svåra vasomotoriska symtom (VMS) förknippade med menopaus (se avsnitt 5.1 i produktresumén). Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne; samtidig användning av måttliga eller starka CYP1A2-hämmare; känd eller misstänkt graviditet. Varningar och försiktighet inkluderar: Innan behandling ska noggrann diagnos ställas och fullständig anamnes (inkl. familjeanamnes) tas. Regelbundna kontroller enligt klinisk praxis måste utföras. Leverfunktionstester (LFT) måste utföras innan behandling, varje månad under de tre första månaderna, och därefter baserat på klinisk bedömning. Behandling skall inte initieras eller fortsätta om LFT möter prespecificerade kriterier. Patienter ska informeras om tecken och symtom på leverskada och uppmanas att omedelbart kontakta läkare om sådana uppstår. Rekommenderas inte vid kronisk måttligt eller kraftigt nedsatt leverfunktion (Child-Pugh klass B och C), eller vid svår nedsatt njurfunktion. Rekommenderad övervakning av leverfunktionen vid känd eller misstänkt leversjukdom. Rekommenderas inte med samtidig användning med östrogen (undantaget lokala vaginala preparat). Har inte studerats i kvinnor över 65 år. Data från djurstudier har visat reproduktionstoxikologiska effekter. Subventioneras endast där menopausal hormonbehandling är kontraindicerad eller där menopausal hormonbehandling avbrutits av medicinska skäl.

Astellas Pharma AB, Tel: 040-650 15 00. Produktresumé 2025-02. För ytterligare information, förpackningar och priser, se www.fass.se.