In addition to growth hormone deficiency (GHD) in patients 2.5 years and older, Sogroya® is the first and only once-weekly growth hormone treatment approved for children 2.5 years and older with Idiopathic Short Stature (ISS), who are not growing and have Noonan Syndrome (NS), and who are short (in stature) and were born small (Small for Gestational Age-SGA) with no catch-up growth by age 2.
Is Sogroya® safe and effective for my child?
For kids with ISS, NS, or born SGA, getting their growth hormone injection once a week instead of every day could be a game-changer. Ask your doctor if once-weekly Sogroya® could be the right choice for your family. To learn more about its efficacy and safety, keep reading.
Sogroya® is used to treat children 2.5 years of age and older who: are short (in stature) and were born small (Small for Gestational Age-SGA) and have not caught up in growth by age 2 years; are not growing and have Noonan Syndrome (NS); and have Idiopathic Short Stature (ISS).
In a 1-year (52-week) study of 88 children who had never been treated for Idiopathic Short Stature (ISS), Sogroya® was compared with a daily growth hormone (GH) treatment called somatropin.
The main goal of this study, REAL8, was to see if children with ISS who took Sogroya® once per week grew at a similar rate as children who took the daily GH treatment.
From year 0 to year 1:
Children taking Sogroya® (0.24 mg/kg/week) grew ~4 inches (10.2 cm), on average, at 1 year.
Children taking daily GH (0.050 mg/kg/day) grew ~4.1 inches (10.5 cm), on average, at 1 year.
These results are from the REAL8 main trial phase (Week 0 to Week 52). A total of 88 children 2.8-10.8 years of age with a confirmed diagnosis of ISS were randomized to receive Sogroya® 0.24 mg/kg/week or daily somatropin 0.050 mg/kg/day. In the US, a 0.05 mg/kg/day dose of daily somatropin is considered less than the maximum dose (0.067 mg/kg/day) approved for use for children with ISS.
The following side effects occurred in 10% or more of children being treated with Sogroya® for ISS:
Talk to your child’s doctor for medical advice about these and other possible side effects.
In a 1-year (52-week) study of 142 children who had never been treated for being Small for Gestational Age (SGA), Sogroya® was compared with a daily growth hormone (GH) treatment called somatropin.
The main goal of this study, REAL8, was to see if children who are SGA and who took Sogroya® once per week grew at a similar rate as children who took the daily GH treatment.
From year 0 to year 1:
Children taking Sogroya® (0.24 mg/kg/wk) grew ~4.3 inches (11 cm), on average, at 1 year.
Children taking daily GH (0.067 mg/kg/day) grew ~4.4 inches (11.1 cm), on average, at 1 year.
Children taking daily GH (0.035 mg/kg/day) grew ~3.7 inches (9.4 cm), on average, at 1 year.
These results are from the REAL8 main trial phase (Week 0 to Week 52). A total of 142 children 2.6-10.7 years of age with a confirmed diagnosis of SGA were randomized to receive Sogroya® 0.24 mg/kg/week, daily somatropin 0.035 mg/kg/day or daily somatropin 0.067 mg/kg/day. In the US, a 0.035 mg/kg/day dose of daily somatropin is less than maximum dose (0.067 mg/kg/day) approved for use in pediatric patients with SGA.
The following side effects occurred in 10% or more of children being treated with Sogroya® for SGA:
Talk to your child’s doctor for medical advice about these and other possible side effects.
In a 1-year (52-week) study of 77 children who had never been treated for Noonan Syndrome (NS), Sogroya® was compared with a daily growth hormone (GH) treatment called somatropin.
The main goal of this study, REAL8, was to see if children with NS who took Sogroya® once per week grew at a similar rate as children who took the daily GH treatment.
From year 0 to year 1:
Children taking Sogroya® (0.24 mg/kg/wk) grew ~4.1 inches (10.4 cm), on average, at 1 year.
Children taking daily GH (0.050 mg/kg/day) grew ~3.6 inches (9.2 cm), on average, at 1 year.
These results are from the REAL8 main trial phase (Week 0 to Week 52). A total of 77 children 2 to 11.1 years of age with a confirmed diagnosis of NS were randomized to receive Sogroya® 0.24 mg/kg/week or daily somatropin 0.050 mg/kg/day. In the US, 0.05 mg/kg/day of daily somatropin is less than maximum dose (0.066 mg/kg/day) approved for use in pediatric patients with NS.
The following side effects occurred in 10% or more of children being treated with Sogroya® for NS:
Talk to your child’s doctor for medical advice about these and other possible side effects.
How to use Sogroya® for children
Use our helpful tools for learning how to take Sogroya®.
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Daily injections can be a challenge
If your family struggles with daily growth hormone injections, you’re not alone. A once-weekly option might be a better fit.
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