US Pharm. 2010;35(10):102.Sandoz announced that the FDA has approved its human growth hormone omnitrope (somatropin [rDNA origin] for injection) for the treatment of idiopathic short stature (ISS). Recently, omnitrope was also approved for the treatment of children with growth failure due to Prader-Willi syndrome and of those who are small for gestational age. The term ISS describes children or adolescents who are very short compared with others of their age, but have no identifiable disorder or no evidence of systemic, endocrine, nutritional, or chromosomal abnormalities. Omnitrope was originally approved for pediatric patients who have growth failure and for replacement therapy in adults with growth hormone deficiency.
The company also announced the launch of the Sandoz Patient Assistance Program to help eligible patients gain access to omnitrope, part of a suite of services designed to help enhance affordability for patients taking the drug. These services include in-home injection training and the “Save As You Grow” program, which can save patients out-of-pocket costs.