FDA Approves Lilly’s Type 2 Diabetes Drug Trulicity
The FDA approved Eli Lilly’s diabetes drug Trulicity as a once-weekly subcutaneous injection to improve blood sugar levels, along with diet and exercise, in adults with the type 2 form of the disease.
Trulicity (dulaglutide) won the agency’s greenlight based on six clinical trials of 3,342 patients. Those who took the drug showed improvement in blood sugar control based on reductions in the HbA1c level.
As part of the approval, the FDA is requiring several post-marketing studies, including a clinical trial to evaluate dosing, efficacy and safety in pediatric patients, and a clinical trial comparing the drug with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.