U.S. Food and Drug Administration (FDA) has approved somapacitan ( Sogroya) to treat children aged 2.5 years and older with growth hormone deficiency. The orphan drug was previously approved to treat adults with growth hormone deficiency.
Somapacitan is administered subcutaneously once a week and available in 5 mg, 10 mg or 15 mg doses.
Growth hormone deficiency is a rare endocrine disorder characterized by insufficient levels of growth hormone being secreted from the pituitary. A hallmark feature of this condition is growth retardation or deceleration, as well as short stature. Additionally, growth hormone deficiency is associated with metabolic abnormalities, impaired cardiovascular function, fatigue, delayed or incomplete puberty, osteoporosis, and reduced muscle strength.
The FDA approval was largely based on data from the phase 3 REAL4 study. In the study, treatment-naïve children with growth hormone deficiency, aged 2.5 – 11 years, were given once-weekly somapacitan (n=132) or daily somatropin (n=68) for 52 weeks. The results showed that once-weekly somapacitan was comparable to daily somatropin for the primary endpoint of annualized height velocity (11.2 cm/year vs. 11.7 cm/year, respectively). The most common adverse reactions in the study were nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reactions. Results from this study were published in the Journal of Clinical Endocrinology and Metabolism.
To learn more about the latest clinical research in growth hormone deficiency and obtain CME credit, visit checkrare.com/learning/p-gh-deficiency-research-highlights/
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