FDA approves once-weekly GLP-1 receptor agonist for type 2 diabetes

FDA has approved dulaglutide (Trulicity, Eli Lilly) to treat type 2 diabetes mellitus.

The drug is a once-weekly subcutaneous injection used to improve glycemic control and is indicated as an adjunct to diet and exercise in the management of type 2 diabetes in adults. As a glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide helps normalize blood sugar levels.

“Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” explained Mary Parks, MD, who is the deputy director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research. Dulaglutide is a new treatment option that, as Dr. Parks further commented “can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes.”

It is estimated that more than 380 million people suffer from diabetes worldwide, with over 29 million affected by the disease in the United States. More than 90% of U.S. cases are diagnosed as type 2 diabetes. The risk for serious complications that can manifest over time with this progressive disease include cardiovascular disease, nerve and kidney damage, and blindness.

FDA based their approval of the new drug on six clinical trials evaluating the safety and effectiveness of dulaglutide in 3342 patients. The GLP-1 receptor agonist was used alone or in combination with other commonly prescribed diabetes medications, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Improvement in blood glucose control, as seen in reductions in hemoglobin Alc levels, was observed in patients who received dulaglutide.

FDA approved dulaglutide with a risk evaluation and mitigation strategy (REMS) for healthcare professionals. Labeling will include a Boxed Warning about an increased risk for thyroid C-cell tumors based on studies in rats. It is not known, however, whether dulaglutide causes thyroid C-cell tumors in humans, including the thyroid cancer called medullary thyroid carcinoma (MTC).

FDA has also required that five post-marketing studies of dulaglutide be undertaken by its manufacturer. Among these are a clinical trial to evaluate its use in pediatric patients, an MTC case registry to identify any increased incidence related to dulaglutide, and a cardiovascular outcomes trial to evaluate its cardiovascular risk in patients at high risk of cardiovascular disease.

Dulaglutide will be made available in 0.75 mg and 1.5 mg single-dose pens for U.S. adults later this year. It is also currently under review by the European Medicines Agency.