Omnitrope

Omnitrop Sandoz Treatment of children and adults with certain forms of growth disturbance... 

Somatropin (Accretropin, Genotropin, Humatrope, Nutropin, Norditropin, Omnitrope, Saizen, Serostim, Tev-Tropin, Zorbtive)... 

Omnitrope should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumor therapy complete prior to the institution of therapy Omnitrope should be discontinued if there is evidence of tumor growth... 

Case Study 2 Omnitrope [Somatropin (rDNA Origin)]... 

The FDA s expectations in this regard are apparent in their description of the CMC data package supporting the comparability of Omnitrope to the innovator protein Genotropin. The FDA asserted [18] ... 

Comparability Program As with the Fortical case study, Omnitrope and Genotropin differed in certain aspects. As such, Sandoz was required to submit substantial data to establish that Omnitrope was sufficiently similar to Genotropin to warrant reliance on FDA s finding of safety and effectiveness for Genotropin to support the approval of Omnitrope [18]. 

Nonclinical PK/IA Minimal toxicity data were needed on recombinant HGH (rHGH) itself, since the clinical effects of HGH excess are well established and understood and are extensively documented in published literature. Sandoz performed toxicity studies to appropriately qualify impurities specific to Omnitrope, that is, a subacute 14-day rat study and a local (skin) tolerance study in rabbits. Further, the bioactivity of Omnitrope was assessed using a validated weight gain bioassay using a hypophysectomized (growth-hormone-deficient) rats. 

U.S. Department of Health and Human Services, Food and Drug Administration, Omnitrope (somatropin [rDNA origin]) questions and answers, available http //www.fda.gov/ cder/drug/infopage/somatropin/qa.htm, accessed Dec. 21, 2006. 

Lorenzo A. (2006). As First Step In Biogeneric Debate, Omnitrope Cleared. BioWorld. 

The longitudinal, postmarketing, observational PATRO children study (N = 1837, mean age = 9.33 years, 56.9% male) found that adverse events associated with Omnitrope with an incidence rate >0.001 (based on 2851.16 patient years) were headache, hypothyroidism, arthralgia, pain in extremity, injection-site haematoma, decreased glucose tolerance, asthenia, injection-site pain, increased blood creatine, phosphokinase and myalgia [36 -]. There were no confirmed cases of diabetes (type 1 or 2) or malignancy related to treatment and no anti-hGH antibodies have been found in a subset of 30 patients. 

Pfaffle R, Schwab KO, Marginean O, Walczak M, Szaledd M, Schuck E, et ah Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope((R)) in children requiring growth hormone treatment. Ther Adv Endocrinol Metab 2013 4(1) 3-11. Epub 2013/03/22. 

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