The CHMP has issued a positive opinion for the use of Byetta (exenatide twice-daily) as an add-on therapy to basal insulin for the treatment of type 2 diabetes in adults who have not achieved adequate glycaemic control.
The treatment, to be used with or without metformin and/or Actos (pioglitazone), demonstrated in clinical trials that it can reduce glycaemic control levels.
Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, says Byetta “has potential as a complementary treatment approach for several reasons”.
The double-blind, 30-week clinical trial evaluating Byetta as an add-on therapy to insulin glargine showed that patients who may have been at risk of hypoglycaemia reduced their glargine dosage by a fifth.
Then, five weeks after randomisation, all patients had insulin doses titrated to achieve target fasting glucose levels. After the full 30 weeks of treatment, Byetta demonstrated a statistically significant reduction in hypoglycaemia compared to placebo, lowering levels by 1.7% from a baseline of 8.3%.
“Byetta is given in a fixed-dose regimen,” said Christian Weyer. “Its effects contribute to improved glycaemic control after meals, complementing the control of fasting blood sugar achieved with basal insulin. And in a clinical study, patients using Byetta with insulin glargine achieved better glycaemic control, without weight gain or an increased risk of hypoglycaemia, than patients using insulin glargine without Byetta.”
The injection was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes.
In November last year, Amylin and Eli Lilly announced they had amicably terminated their decade-long collaboration on the treatment.