Eli Lilly and Company Gets Thumbs Up From FDA For Diabetes Drug Trulicity

Eli Lilly and Company Gets Thumbs Up From FDA For Diabetes Drug Trulicity

September 19, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The U.S. Food and Drug Administration has given the thumbs up to Eli Lilly’s (LLY) new injectable diabetes drug Trulicity, the regulator said late Thursday.

Trulicity would be administered as a weekly injection to improve blood sugar control in patients with Type 2 diabetes, which accounts for around 90 percent of all cases in the United States.

The company said it is was pleased with the approval.

"We are delighted with the approval of Trulicity. Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin," said Enrique Conterno, president, Lilly Diabetes. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes."

Trulicity is a GLP-1 agonist, a growing field of medicines which stimulate the pancreas to create additonal insulin after meals. Eli Lilly had presented data to the FDA based on six studies in 3,342 patients that showed improvements in blood sugar control, but with the caveat that some of the rats used in the tests developed thyroid cancer, though no direct correlation with the drug therapy was shown.

Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise, nor has it been studied in patients with a history of pancreatitis.

Lilly said it plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. It is the first regulatory approval for Trulicity globally, though it has also been submitted to the European Medicines Agency and other regulatory bodies.

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