Regulatory Decision Summary for Adlyxine

The efficacy of Adlyxine was adequately supported in 15 randomized Phase 3 clinical trials. Across these trials, 2,869 patients received lixisenatide. Adlyxine improved glycemic control when added to the regimens of patients inadequately controlled on either metformin, a sulfonylurea (± metformin), pioglitazone (± metformin), or a basal insulin (± metformin). Based on the primary efficacy endpoint in 6 of the Phase 3 studies designated as pivotal by Health Canada, statistically significant placebo-adjusted reductions in HbA1c from -0.36% to -0.74% were observed following 12 to 26 weeks of treatment. Other, secondary glycemic control endpoints were generally consistent with the HbA1c results.

The safety of Adlyxine was adequately supported in data from 8224 patients exposed to lixisenatide across Phase 2/3 studies. Overall, the safety profile of Adlyxine was comparable to that of other glucagon-like peptide 1 receptor agonists. The most frequent adverse events seen with Adlyxine were nausea, vomiting, hypoglycemia, headache, diarrhea, and dizziness. Hypoglycemia occurred most often in patients already receiving a background regimen of a sulfonylurea or basal insulin. Injection site reactions were also commonly reported. Some patients developed anaphylaxis reactions to Adlyxine. Cases of pancreatitis were observed but an increased incidence in lixisenatide treated patients could not be concluded. Patients who developed antibodies to lixisenatide (roughly 70%) had a diminished glycemic response, as well as more frequent allergic and injection site reactions.

Based on the available data, the overall benefit-harm-uncertainty profile of Adlyxine is considered favourable.