Can fezolinetant be used in patients older than 65 years?

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Prescribing Information including BOXED WARNING

The use of fezolinetant in women over 65 years of age is not contraindicated, although its use has not yet been studied in this age group

In the Phase 3 SKYLIGHT trials, fezolinetant 45 mg significantly reduced vasomotor symptom (VMS) frequency regardless of age in patients 40 to 65 years old.¹ Baseline age (< 55 years and ≥ 55 years) did not have an impact on the incidence and type of treatment-emergent adverse events reported, nor on the risk of hepatic safety^2,3
An ongoing real-world Phase 4 study to assess the change from baseline in vasomotor symptom bother in women initiating nonhormonal therapy, including fezolinetant, will recruit participants aged between 40 and 75 years³

In a pooled efficacy analysis of the Phase 3 SKYLIGHT 1 and 2 trials, 1022 women aged ≥ 40 to ≤ 65 years were separated into subgroups of < 50 years, ≥ 50 to ≤ 60 years, and > 60 years old.¹ Compared with placebo at Week 12, fezolinetant 45 mg significantly reduced VMS frequency in all age groups (p < 0.05; Figure 1), and significantly reduced VMS severity (p < 0.05), except in the < 50 years subgroup (Figure 2).

Figure 1. Change in VMS frequency from baseline to Week 12 by baseline age in the full analysis set (all randomized participants assessed according to the randomization at first dose).¹

The number of participants with baseline data are shown.

P values were calculated without multiplicity adjustment.

Total number of participants – Fezolinetant 30 mg: n = 339, Fezolinetant 45 mg: n = 341, Placebo: n = 342.

Adapted from: Santoro NF, Menopause, 2024.

Figure 2. Change in VMS severity from baseline to Week 12 by baseline age in the full analysis set (all randomized participants assessed according to the randomization at first dose).¹

The number of participants with baseline data are shown.

P values were calculated without multiplicity adjustment.

Baseline results include moderate and severe incidences while post-baseline results include mild, moderate, and severe incidences.

Total number of participants – Fezolinetant 30 mg: n = 339, Fezolinetant 45 mg: n = 341, Placebo: n = 342.

Adapted from: Santoro NF, Menopause, 2024.

Santoro N, Nappi R, Neal-Perry G, et al. Fezolinetant treatment of moderate-to-severe vasomotor symptoms due to menopause: Effect of intrinsic and extrinsic factors in two phase 3 studies (SKYLIGHT 1 and 2). Menopause. 2024;31(4):247-257. Available at: https://doi.org/10.1097/gme.0000000000002340.
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):737-747. Available at: https://doi.org/10.1097/aog.0000000000005114.
Data on file.