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 clinically meaningful VMS reductions and was evaluated for safety for up to a year2

Study design

The efficacy of VEOZA was evaluated in postmenopausal women with moderate to severe VMS in two 12-week, randomised, placebo-controlled, double-blind phase 3 studies, followed by a 40-week non-placebo controlled extension treatment period2

 

Coprimary endpoints: Mean change from baseline in moderate to severe VMS frequency and severity2

 

Clinically meaningful is defined as a reduction in ≥2 hot flushes per 24 h versus placebo2

VMS=vasomotor symptoms

Fewer and less severe VMS episodes from baseline with VEOZA (pooled data)2

VEOZA provides statistically significant relief from the number and severity of daily hot flushes and night sweats compared with placebo2

Bar chart showing the mean change from baseline in frequency of moderate to severe VMS over 24 hours at week 4

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

 

LS mean: Least squares mean estimated from a mixed model for repeated measures analysis of covariance2

 

Data cointain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 22

 

Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment2

 

Figure adapted from reference 2

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

Reduction in severity of VMS episodes2-4

VEOZA provided statistically significant reductions in the severity of VMS episodes at weeks 4 and 122

BLN=baseline; SE=standard error; VMS=vasomotor symptoms; WK=week

 

Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 22

 

Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment2

 

Figure made by Astellas based on the references 2-4

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

Patients taking VEOZA experienced a reduction 
in VMS episodes at weeks 4 and 12 (coprimary endpoints), which was sustained through 
52 weeks)3,4

Mean change in frequency of VMS from baseline to each week up to week 12 was a secondary endpoint and was not adjusted for multiplicity3,4


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 only3,4

 

Figure adapted from reference 3 and 4

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

VEOZA was studied for safety and tolerability for 1 year2

The safety of VEOZA was evaluated in phase 3 clinical studies with 2 203 postmenopausal women receiving VEOZA2

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 non-placebo controlled treatment2-4

SKYLIGHT 4

One phase 3, 52-week, randomised, placebo-controlled, double-blind study evaluating safety5

Adverse reactions for VEOZA (fezolinetant 45 mg)6

Table of common adverse reactions and frequency: diarrhoea, abdominal pain, insomnia, and increased alanine aminotransferase
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 (≥3%) with VEOZA were diarrhoea (3.2%) and insomnia (3.0%)6
  • The most frequent adverse reactions leading to dose discontinuation with VEOZA were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%)6
  • There were no serious adverse reactions reported at an incidence greater than 1% across the total study population. On VEOZA, four serious adverse reactions were reported. The most serious adverse reaction was an event of endometrial adenocarcinoma (0.1%)6

VEOZA was assessed for endometrial safety

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 observed6
  • 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

 

REFERENCES: 1. VEOZA SmPC §4.1 02.2024. 2. VEOZA SmPC §5.1 02.2024. 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. 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. 6. VEOZA SmPC § 4.8 02.2024.

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. 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 2024-02. För ytterligare information, förpackningar och priser, se www.fass.se.