Systemic hypersensitivity reactions and immune mediated injection site adverse events but incidence low round assessment of benefit-risk balance The benefit-risk balance of dulaglutide, given the proposed usage, is favourable. First round recommendation regarding authorisation Based on the clinical data included, it is recommended the application is approved. Clinical questions Pharmacokinetics No questions submitted. Pharmacodynamics No questions submitted. Efficacy No questions submitted. Safety No questions submitted. References Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus CPMP/EWP/1080/00 30 May 2002, adopted by TGA 23 October 2002 Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type – 2 FDA 2008. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990; 28(2):72-78.
Systemic hypersensitivity reactions and immune mediated injection site adverse events but incidence low round assessment of benefit-risk balance The benefit-risk balance of dulaglutide, given the proposed usage, is favourable. First round recommendation regarding authorisation Based on the clinical data included, it is recommended the application is approved. Clinical questions Pharmacokinetics No questions submitted. Pharmacodynamics No questions submitted. Efficacy No questions submitted. Safety No questions submitted. References Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus CPMP/EWP/1080/00 30 May 2002, adopted by TGA 23 October 2002 Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 FDA 2008. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990; 28(2):72-78.
auspar-dulaglutide-rch-150727-cer.docx