Growth improvements were similar between children taking somapacitan for 3 years and those who initially took daily growth hormone and switched to somapacitan at 52 weeks.
The once-weekly hormone therapy shows continued efficacy and tolerability for up to 3 years, according to new data from an extended phase 3 trial.REAL4 is a randomized, open-label, multinational, phase 3 trial of once-weekly somapacitan .
Children with growth hormone deficiency were assigned either once-weekly somapacitan or once-daily GH for 52 weeks After 1 year, the once-daily group was switched to once-weekly somapacitan, and both groups were followed for 2 additional years.125 participants in the somapacitan continued treatment group and 63 participants in the switch group completed 3 years of treatment.
Growth improvements were similar between the two groups: At year 3, average HV was 7.4 cm/yr in the continued treatment group and 7.8 cm/yr in the switch group."Once-weekly somapacitan showed sustained efficacy and tolerability for 3 years, as well as for 2 years following the switching from daily GH treatment in this pivotal phase 3 REAL4 trial," the authors write."The safety profile of somapacitan was similar to the well-known safety profile of daily GH.
GH Deficiency Growth Hormone Deficiency (GHD) GHD - Growth Hormone Deficiency Children Child Childhood Pediatrics Kids Growth Hormone Body Mass Index BMI Bones Endocrine Society Grant Hormone Therapy Hormonal Therapy Minnesota
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