The Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s new Type 2 diabetes treatment Trulicity, but the approval comes with a black box warning about an increased risk of thyroid cancer.
Trulicity is an injectable drug in a family of type 2 diabetes medications known as glucagon-like peptide-1, or GLP-1, receptors. These drugs are in class of medications known as incretin mimetics that help control blood sugar levels in patients who do not produce enough insulin. Trulicity can be used as a single treatment or in combination with other commonly prescribed diabetes drugs including metformin, Actos and insulin Humalog.
The new treatment was approved based on the outcome of several studies that compared Trulicity to four other commonly used medications – metformin, Januvia, Byetta and Lantus. Previous studies on laboratory rats showed a risk of thyroid C-cell tumors, which led the FDA to approve the drug only if the drug clearly warned consumers prominently on the drug’s label of the thyroid cancer risk.
Several type 2 diabetes drugs carry cancer risks. The drugs Byetta and Januvia, also incretin mimetics, were recently linked to an increased risk of acute pancreatitis and pancreatic cancer. And, the widely prescribed drug Actos has been linked to an increased risk of bladder cancer.
Eli Lilly, which partnered with Japanese drug maker Takeda Pharmaceutical Co., on the blockbuster drug Actos, was ordered to pay $3 billion in punitive damages after a federal court jury found the companies guilty of covering up bladder cancer risks with Actos. Takeda was ordered to pay $6 billion in that lawsuit.