Growth Hormone For Short Stature
The FDA has approved a supplemental New Drug Application for somatropin (of rDNA origin for injection) (Genotropin) to treat growth failure associated with Turner syndrome in patients whose bones are still capable of growing.
The approval was based on two randomized, open-label, clinical trials in 38 children of short stature with Turner syndrome. Both studies demonstrated statistically significant growth increases from baseline height, and growth responses were greater in the study in which patients received a larger dose.
Turner syndrome is an “orphan disease” that affects an estimated 60,000 girls and women in the U.S. Relatively few people are affected, but treatment is important because there is no cure.
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An early diagnosis of short stature is essential for better outcomes. Blood tests can determine whether one of the two X chromosomes normally found in females is missing or incomplete.
Genotropin has orphan drug status for other growth-related conditions (“small-for-gestational-age” and Prader-Willi syndromes). It is also indicated for growth failure in children with an inadequate secretion of endogenous growth hormone.
