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Efficacy and Safety in Treatment-naïve Patients

heiGHt infographic

heiGHt study design

heiGHt was a randomized, open-label, active-controlled, phase 3 study that compared the efficacy, safety, and tolerability of once-weekly SKYTROFA® versus once-daily somatropin in children with GHD1,2*

Skytrofa Chart Skytrofa Chart

*Annualized height velocity (AHV) at week 52 was the primary endpoint.2

*Annualized height velocity (AHV) at week 52 was the primary endpoint.2

Higher mean AHV versus daily somatropin

SKYTROFA demonstrated higher AHV in a phase 3 clinical trial of 161 treatment-naïve pediatric patients with GHD1,2

Mean AHV at week 52: once-weekly SKYTROFA versus daily somatropin1,2†‡

At week 52, patients receiving once-weekly SKYTROFA had an AHV of 11.2 cm/year compared with 10.3 cm/year for those receiving a daily somatropin.1,2
  • The change in mean bone age from baseline to week 52 was similar with SKYTROFA and daily somatropin, and the observed mean BMI SDS remained within normal range for both groups2,3
Within ± 2.0 SD of the mean.2

Sustained growth was achieved with SKYTROFA in treatment-naïve patients2

Patients treated with SKYTROFA had a greater increase from baseline in height SDS§ compared with patients treated with a daily somatropin at week 52 (1.10 versus 0.96, respectively)2||

§ LS mean by ANCOVA.2
Patients treated with SKYTROFA and daily somatropin had an increase in height SDS from baseline (SE) of 1.10 (0.04) and 0.96 (0.05) at week 52, respectively. Estimated difference = 0.14 SDS.2

Established safety profile

The safety profile of SKYTROFA has been established in pediatric patients aged 1 year and older who weigh at least 11.5 kg1

Low immunogenicity, with no neutralizing antibodies detected2

Only 6.7% (7 of 105) of patients showed detectable binding antibodies2

  • Some patients taking SKYTROFA experienced mild injection-site reactions2
  • Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products1

AEs reported in ≥ 5% of SKYTROFA-treated pediatric patients and more frequently than in daily somatropin-treated# pediatric patients (52 weeks of treatment)1

(n = 105)
Daily somatropin
(n = 56)
n (%) n (%)
Viral infection 16 (15%) 6 (11%)
Pyrexia 16 (15%) 5 (9%)
Cough 11 (11%) 4 (7%)
Nausea and vomiting 11 (11%) 4 (7%)
Hemorrhage 7 (7%) 1 (2%)
Diarrhea 6 (6%) 3 (5%)
Abdominal pain 6 (6%) 2 (4%)
Athralgia and arthritis# 6 (6%) 1 (2%)
The etiology of hemorrhage in the SKYTROFA treatment group included epistaxis (n = 3), contusion (n = 2), petechiae (n = 1), and eye hemorrhage (n = 1).1
# The etiology of arthralgia and arthritis in the SKYTROFA treatment group included arthralgia (n = 5) and reactive arthritis (n = 1).1

See if SKYTROFA is right for your patients who want to switch from daily GH

Review phase 3 clinical data for children switching from daily GH


Explore long-term safety and efficacy

See long-term data for children taking SKYTROFA, including those who completed treatment

enliGHten DATA