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Long-term Safety and Efficacy

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enliGHten study design

enliGHten was an open-label extension study of children with GHD who had previously participated in phase 3 SKYTROFA® trials1

Skytrofa Chart Skytrofa Chart

Long-term safety and tolerability

  • Follow-up for up to 6 years* demonstrated a safety profile consistent with prior observations (heiGHt and fliGHt), and no new signals1,2
    • Most common AEs following mean 1.4 years of SKYTROFA treatment were upper respiratory tract infection (21.1%), nasopharyngitis (11.1%), and cough (8.7%)1
  • There were no TEAEs that led to discontinuation of study drug in the full safety population (n = 306)2†

Adverse event summary in treatment completers2

Treatment completers
(n = 81)
TEAEs 67 (82.7%)
Drug-related TEAEs 7 (8.6%)
TEAEs leading to discontinuation of study drug 0

Treatment completers:

  • Subset of patients who completed SKYTROFA treatment because it was determined by the physician that treatment for pediatric GHD was no longer necessary2
  • These patients have completed their SKYTROFA treatment journey, providing an overview of its effect from initiation to completion. Many patients will go on to resume GH treatment as adults with available therapies

Treatment completers achieved genetic height potential2

59% of those who completed their SKYTROFA treatment (n = 81) achieved or exceeded average parental height2

Height SDS of treatment completers approached the population mean2

*Mean duration of treatment was 4.1 years (maximum 6 years).2
Full safety population includes all patients who enrolled in either the heiGHt or the fliGHt trial.1
Mean duration of treatment was 3.2 years (maximum 5.3 years).2

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Review phase 3 clinical data for children switching from daily GH