Eli Lilly closer to seeking approval for new type 2 diabetes drug
Late stage research on Eli Lilly and Co.’s potential new type 2 diabetes medication dulaglutide shows it was better than two other drugs at lowering blood sugar levels. The drug company says it hopes to apply for approval from United States drug regulators next year, but the timing depends on the completion of Food and Drug Administration (FDA) requirements for an assessment of the drug’s cardiovascular risk.
Eli Lilly reported that two injections of dulaglutide lowered blood sugar levels better than twice-daily injections of exenatide and the oral treatments metformin and sitagliptin. More details of the study that provided this detail is expected to be announced at scientific meetings in 2013 and 2014.
The FDA requires makers of type 2 diabetes drugs to prove that their medications do not increase the risk of heart attacks or other cardiovascular problems before they are considered for approval. The requirement was established following concerns in recent years of the safety of type 2 diabetes treatments.
For example, in 2010, the FDA put severe restrictions on Avandia after it was linked to fatal heart attacks. Avandia is in a class of diabetes medications known as thiazolidinediones, or TZDs. Actos, another TZD, was not associated with as great of a cardiovascular risk as Avandia, but in 2011, the FDA issued a warning that Actos increased the risk for bladder cancer.
Eli Lilly’s diabetes treatments represent a large portion of its product portfolio. The company also makes the insulin drugs Humalog and Humulin.
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