BYDUREON(exenatide)

BYDUREON (exenatide) is a prolonged-release formulation approved for the treatment of type 2 diabetes. The exenatide prolonged release formulation received EU approval on 17 June 2011 and US approval on 27 January 2012. BYDUREON BCise received US approval on 20 October 2017. A Type II variation application for a paediatric indication was submitted on 27 July 2021, with an intention to submit in Q4 2021.

In a double-blind, placebo-controlled, randomized, multicenter Phase 3 study, BYDUREON demonstrated a mean HbA1c change from baseline (LS mean difference) of -0.85% compared to control. The EQW group showed an HbA1c change from baseline (LS mean) of -0.36%, while the placebo group showed a change of 0.49%. Fasting Plasma Glucose (FPG) change from baseline (LS mean difference) was -1.20 mmol/L (EQW vs Control). Body weight change in the EQW group was -0.59 kg, compared to +0.63 kg in the placebo group. The proportion of patients achieving HbA1c goals (<6.5%, <=6.5%, and <7%) was 15 to 23% higher with BYDUREON.

Safety findings included an overall incidence of Adverse Events (AEs) of 61% in the EQW group versus 74% in the placebo group. The incidence of Serious Adverse Events (SAEs) in the EQW group was 3.4%. Injection site reactions occurred in 8.5% of patients. Antibodies to exenatide were detected in 93.0% of patients, with 63% having high titer antibodies. Among adult patients, 45% had low titer antibodies and 12% had high titer antibodies.