Growth failure, treatment

Human growth hormone, used as a human pharmaceutical, is approved for only one indication in the United States, treatment of growth failure owing to hGH deficiency, a condition known as pituitary dwarfism. However, clinical trials are under way to test its efficacy in Turner s syndrome, bums, wound healing, cachexia, osteoporosis, constitutional growth delay, aging, malnutrition, and obesity. 

Mecasermin rinfibate (Iplex and Increlex ) is the only recombinant once-daily IGF-I replacement therapy for the treatment of growth failure in children with severe primary IGF-I deficiency or with GH gene deletions who have developed neutralizing antibodies to GH. This product has not been evaluated in patients with GH deficiency aside from the genetic abnormalities. 

Norditropin Novo Nordisk Treatment of growth failure in children due to inadequate growth hormone secretion... 

Norman Carl Wetzel, The Treatment of Growth Failure in Children, NEA Service, Cleveland, Ohio, 1948. 

Fine, R.N., E.C. Kohaut, D. Brown, and A.J. Perlman, Growth after recombinant human growth hormone treatment in children with chronic renal failure report of a multicenter randomized double-blind placebo-controlled study. Genentech Cooperative Study Group. J Pediatr, 1994.124(3) 374-82. 

H. Other considerations Protropin has been designated an orphan product for use in the treatment of growth failure due to... 

A small number of children with growth failure have severe IGF-1 deficiency that is not responsive to exogenous GH. Causes include mutations in the GH receptor and development of neutralizing antibodies to GH. In 2005, the FDA approved mecasermin for treatment of severe IGF-1 deficiency that is not responsive to GH. Mecasermin is a complex of recombinant human IGF-1 (rhIGF-1) and recombinant human insulin-like growth factor-binding protein-3 (rhIGFBP-3). 

Rivkees SA, Danon M, Herrin J. Prednisone dose limitation of growth hormone treatment of steroid-induced growth failure. J Pediatr 1994 125(2) 322-5. 

Haffner D, Nissel R, Wuhl E, Schaefer F, Bettendorf M, Tonshoff B, Mehls O. Metabolic effects of long-term growth hormone treatment in prepubertal children with chronic renal failure and after kidney transplantation. 

The German Study Group for Growth Hormone Treatment in Chronic Renal Failure. Pediatr Res 58. 1998 43(2) 209-15. 

On July 30, 2003, Sandoz submitted a 505(b)(2) application for the approval of its recombinant HGH product (recombinant somatropin) indicated for long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone and for long-term replacement therapy in adults with GHD of either childhood or adult onset. This application relied in part on data submitted in the Genotropin NDA. 

Rutledge ML, Hawkins EP, Langston C. Skeletal muscle growth failure induced in premature newborn infants by prolonged pancuronium treatment. J Pediatr 1986 109(5) 883-6. 

Hertel NT, Holmberg C, Ronnhohn KA, Jacobsen BB, Olgaard K, Meeuwisse GW, Rix M, Pedersen FB. Recombinant human growth hormone treatment, using two dose regimens in children with chronic renal failure— a report on linear growth and adverse effects. J Pediatr Endocrinol Metab 2002 15(5) 577-88. 

Long-term treatment of children with growth failure due to lack of the endogenous hormone... 

Somatrem, an anterior pituitary hormone, is used in longterm treatment of growth failure from lack of adequate endogenous growth hormone secretion. 

The introduction of rDNA human growth hormone (hGH) (70), previously isolated from cadaver pituitaries, greatly improved the long-term treatment of children who have growth failure caused by a lack of adequate endogenous hGH. The major, circulating form of human pituitary hGH is a globular protein of 191 amino acids in... 

---