Health-related quality of life in pre-pubertal children with pediatric growth hormone deficiency: 12-month results from a Phase 3 clinical trial of once-weekly somatrogon versus once-daily somatropin
Conclusion: Treatment for 12 months with once-weekly somatrogon or once-daily somatropin resulted in comparable improvements in HRQoL among children with pGHD. Lower HRQoL perceived by parents/caregivers possibly reflect children's tendency to emphasize adaptation. These results suggest that evaluation of HRQoL could help support treatment decisions in children with pGHD treated with growth hormone.NCT02968004.PMID:38053515 | DOI:10.1080/03007995.2023.2290623 (Source: Current Medical Research and Opinion)
Source: Current Medical Research and Opinion - December 6, 2023 Category: Research Authors: Jane Loftus Julia Quitmann Srinivas Rao Valluri Source Type: research
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
ConclusionsThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as...
Source: Drug Safety - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in
Children Born Small for Gestational Age
This study was
conducted to assess the long-term efficacy and safety of GH treatment in
children born SGA. One hundred and twenty prepubertal SGA children who did not
achieve catch-up growth with height remained less than –2 standard
deviations (SD) below gender-specific height were enrolled in this two-year,
randomized, dose-comparative study followed by an extension study of up to 10
years. Daily subcutaneous injections of 0.23 mg/kg/week
[low-dose (LD) group] or 0.46 mg/kg/week [high-dose (HD)
group] somatropin were given for 104 weeks...
Source: Hormone and Metabolic Research - September 7, 2023 Category: Endocrinology Authors: Wu, Wei Gong, Chunxiu Li, Yuchuan Hu, Yuhua Gong, Haihong Fu, Junfen Huang, Ke Li, Pin Luo, Xiaoping Tags: Original Article: Endocrine Care Source Type: research
PLGA and PEG based porous microparticles as vehicles for pulmonary Somatropin delivery
Eur J Pharm Biopharm. 2023 Sep 1:S0939-6411(23)00230-8. doi: 10.1016/j.ejpb.2023.08.017. Online ahead of print.ABSTRACTBreakthrough advances in protein therapeutics and sustained release systems continue to fuel innovation in novel, non-invasive polymeric platforms for delivery of biologicals. Despite the bench potential and proof-of-concept work, market analysis still shows biologicals to be predominantly injections. Characterized by insufficient secretion of growth hormone by the pituitary gland, growth hormone deficiency (GHD) is a rare disorder. Currently, chronic somatropin (r-hGH) replacement therapy is only availabl...
Source: European Journal of Pharmaceutics and Biopharmaceutics - September 3, 2023 Category: Drugs & Pharmacology Authors: Srushti Sodha Pardeep Gupta Source Type: research
PLGA and PEG based porous microparticles as vehicles for pulmonary Somatropin delivery
Eur J Pharm Biopharm. 2023 Sep 1:S0939-6411(23)00230-8. doi: 10.1016/j.ejpb.2023.08.017. Online ahead of print.ABSTRACTBreakthrough advances in protein therapeutics and sustained release systems continue to fuel innovation in novel, non-invasive polymeric platforms for delivery of biologicals. Despite the bench potential and proof-of-concept work, market analysis still shows biologicals to be predominantly injections. Characterized by insufficient secretion of growth hormone by the pituitary gland, growth hormone deficiency (GHD) is a rare disorder. Currently, chronic somatropin (r-hGH) replacement therapy is only availabl...
Source: European Journal of Pharmaceutics and Biopharmaceutics - September 3, 2023 Category: Drugs & Pharmacology Authors: Srushti Sodha Pardeep Gupta Source Type: research
Practical management of pediatric growth hormone deficiency with lonapegsomatropin
Lonapegsomatropin (TransCon hGH) is the first FDA approved once-weekly prodrug of somatropin for pediatric growth hormone deficiency (GHD). In the pivotal phase 3 heiGHt trial, lonapegsomatropin demonstrated noninferior and superior annualized height velocity (AHV) and a comparable safety profile to daily somatropin in treatment-na ïve children with GHD. Efficacy and safety were demonstrated in previously treated children with GHD who switched to lonapegsomatropin from their prior daily growth hormone, and long term tolerability, safety and efficacy has been demonstrated in the ongoing open-label extension trial enliGHten...
Source: Journal of Pediatric Nursing - September 1, 2023 Category: Nursing Authors: Terri Lipman Source Type: research
Cost-effectiveness and cost-utility analysis of somatrogon once-weekly injections vs. daily growth hormone injection for treating paediatric growth hormone deficiency in Ireland
CONCLUSION: Somatrogon weekly injections were estimated to result in higher NAH, higher QALYs, lower overall costs and lower costs per cm gained than dGHs, in pGHD.PMID:37527156 | DOI:10.1080/13696998.2023.2228167 (Source: Journal of Medical Economics)
Source: Journal of Medical Economics - August 1, 2023 Category: Health Management Authors: Simone Rivolo Jane Loftus Balazs Peter Marion Fahey Thitima Kongnakorn Source Type: research
