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🏅 FDA Orphan Designation

Sogroya

somapacitan-beco

Manufacturer: Novo Nordisk Pharmaceuticals

Indicated for:
Growth and developmental delay-hypotonia-vision impairment-lactic acidosis syndromeOrphanRare disorder due to inadequate sharing of the placentaShort stature-intellectual disability-eye anomalies-cleft lip/palate syndromeOtomandibular dysplasia associated with monogenic syndromesIdiopathic steroid-resistant nephrotic syndromeLaron syndrome

FDA-Approved Indications (6)

Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH)

Growth failure due to inadequate secretion of endogenous growth hormone (GH)

Population: pediatric ≥2.5 years

Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age

Population: pediatric ≥2.5 years

Growth failure associated with Noonan syndrome (NS)

Population: pediatric ≥2.5 years

Idiopathic Short Stature (ISS)

Population: pediatric ≥2.5 years

Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. • Growth failure associated with Noonan syndrome (NS). • Idiopathic Short Stature (ISS). SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). ( 1 ) • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. ( 1 ) • Growth failure associated with Noonan syndrome (NS). ( 1 ) • Idiopathic Short Stature (ISS). ( 1 ) Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). ( 1 )

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Sogroya
Novo Nordisk Pharmaceuticals
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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.