Eli Lilly and Company's diabetes drug Trulicity (dulaglutide) gets federal approval.
Trulicity (dulaglutide) was approved Wednesday by the U.S. Food and Drug Administration. The once-weekly subcutaneous injection is to improve glycemic control or blood sugar levels in adults with type-2 diabetes.
The newly-approved drug is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps regulate blood sugar levels, the agency said.
"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, according to a news release. "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."
Safety and efficacy of the drug was established via clinical trials that included 3,342 patients with type-2 diabetes. The researchers found that patients who received the diabetes drug had improved control on blood sugar levels.
In the U.S., as many as 26 million people suffer from type-2 diabetes. High blood sugar levels can lead to several chronic health problems.
"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, according to a news release. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type-2 diabetes."
The new drug will carry a boxed warning that describes certain complications of using Trulicity. The drug is known to cause tumors of the thyroid gland (thyroid C-cell tumors). FDA also requires post-marketing studies of Trulicity to assess the safety of the drug in children with diabetes. The company will also be required to test whether the drug causes cancer, heart problems or other health complications.
Common side-effects of the drug included nausea, diarrhea, vomiting, abdominal pain, FDA said.
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