2019
DOI: 10.20945/2359-3997000000190 View full text |Buy / Rent full text
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Abstract: Growth hormone therapy with daily injections of recombinant human growth hormone has been available since 1985, and is shown to be safe and effective treatment for short stature in children and for adult growth hormone deficiency. In an effort to produce a product that would improve patient adherence, there has been a strong effort from industry to create a long acting form of growth hormone to ease the burden of use. Technologies used to increase half-life include depot formulations, PEGylated formulations, p… Show more

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“…The effects of rhGH on the disproportion between the limbs and trunk are largely unknown. The same meta-analysis noted above found only 2 studies in which sitting height was properly evaluated ( 177 ). It progressively increased over 24 months (n=50 children) from -1.5 SD (95% CI -2.4 to -0.58 SD) to -0.47 SD (95% CI -1.2 to +0.22).…”
Section: Some Other Conditions For Which Rhgh Has Been Studied But Do Not Have Fda Approvalmentioning
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“…The effects of rhGH on the disproportion between the limbs and trunk are largely unknown. The same meta-analysis noted above found only 2 studies in which sitting height was properly evaluated ( 177 ). It progressively increased over 24 months (n=50 children) from -1.5 SD (95% CI -2.4 to -0.58 SD) to -0.47 SD (95% CI -1.2 to +0.22).…”
Section: Some Other Conditions For Which Rhgh Has Been Studied But Do Not Have Fda Approvalmentioning
“…Thus, the potential availability of long-acting GH (LAGH) preparations, if safe and effective, would be an advantage to overcome the difficulties of requiring daily injections. Two detailed reviews discussing LAGH data ( 177 , 180 ) and a meta-analysis ( 181 ) comparing LAGH to daily treatment provide information about the various formulations that are becoming available. We will briefly describe a few of these.…”
Section: Long-acting Ghmentioning
“…140,141 Nonetheless, its use is limited by its short serum half-life (tens of minutes to several hours after intravenous or subcutaneous injection, respectively), 142 which mandates frequent administration. 143 Significant effort has been devoted to developing long-acting hGH to overcome this limitation, 144 including Jintrolong, which bears a 40-kDa branched PEG at its N-terminus and was approved for use to treat pediatric hGH deficiency in China in 2017. 145,146 In 2011, Ambrx and collaborators used a Tyr analog OTS(CUA) to install a single AcF at 20 different positions of hGH (Figure 5), with sequence context-dependent yields of 20−70% relative to the natural protein.…”
Section: ■ Comparison Of the Two Methods For Gcementioning
“…148 Nonetheless, due to PEG accumulation in cells of the choroid plexus in primates, and possibly the increasing availability of convenient daily injectables, the development of ARX201 was halted in 2014. 144 Leptin. Diet-induced obesity, and its associated disorders such as type 2 diabetes and non-alcoholic fatty acid liver diseases, the most common being non-alcoholic steatohepatitis (NASH), represent an emerging overwhelming health crisis.…”
Section: ■ Comparison Of the Two Methods For Gcementioning
“…The depot preparation, however, was a highly viscous formulation with somatropin-containing microparticles and was associated with a high degree of injection site reaction ( 7 ). The depot preparation needed to be injected with a large-bore needle, often more than once at a given administration interval and leaving a visible subcutaneous lump ( 8 ). Lonapegsomatropin injections, in contrast, are well-tolerated and readily administered using an autoinjector and fine-gauge needle ( 2 ).…”
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