Eli Lilly's Trulicity approved by FDA
SILVER SPRING, Md. and INDIANAPOLIS — The Food and Drug Administration on Thursday approved Trulicity (dulaglutide), a once-a-week injection to improve blood-sugar levels in adults with Type 2 diabetes.
"Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of Type 2 diabetes.”
Trulicity is manufactured by Eli Lilly and Co, which said it plans to make the drug — in 0.75-mg and 1.5-mg single-dose pens — available in the United States later in the year. The drug has also been submitted for consideration to the European Medicines Agency and other regulatory agencies, according to Lilly.
"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 does not require mixing, measuring or needle attachement and can be administered any time of day.