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FDA accepts new drug application for GLP-1 agonist lixisenatide
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The FDA announced it has accepted the new drug application for lixisenatide, indicated for the treatment of type 2 diabetes.
The new drug application was accepted by the FDA due to results from the GetGoal clinical program which included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin (1,250 patients treated with lixisenatide or placebo in three trials).
According to a press release, lixisenatide demonstrated significant reductions in HbA1c, post-prandial glucose (PPG)-lowering effect and had a favorable effect on body weight in adult patients with type 2 diabetes. The GetGoal results also showed that the drug was safe and well-tolerated by most patients. Mild and transient nausea and vomiting were the most common adverse events, with a limited risk for hypoglycemia.
Data from the ongoing ELIXA trial, a cardiovascular outcome study of lixisenatide in patients who recently experienced an acute coronary event, were also submitted.
According to a press release, the first once-daily prandial GLP-1 receptor agonist was given full approval in the European Union on February 1, 2013 for the treatment of adults with type 2 diabetes to achieve glycemic control in combination with oral glucose-lowering agents and/or basal insulin. The drug will be marketed as Lyxumia there. Lixisenatide is also approved in Mexico for the treatment of adults with type 2 diabetes.