Novo Nordisk Pharma has submitted an application in Japan seeking a label expansion Sogroya Subcutaneous Injection for the treatment of short stature due to growth hormone deficiency without epiphyseal closure.
Novo Nordisk Pharma has submitted an application in Japan seeking a label expansion of its long-acting human growth hormone Sogroya Subcutaneous Injection (somapacitan) for the treatment of short stature due to growth hormone deficiency without epiphyseal closure.
The submission is based on results from the multinational clinical trial program called REAL, enrolling 269 children with growth hormone deficient short stature, including 44 Japanese. Children with this disorder are usually given replacement therapy with human growth hormone preparations that require daily subcutaneous injections. Sogroya, however, as a once-weekly injectable, is expected to improve patent adherence. The drug was approved in Japan in December 2021 for the treatment of adult growth hormone deficiency (only in severe patients).
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