European drug regulators have approved AstraZeneca and Bristol-Myers Squibb’s combination type 2 diabetes drug Xigduo, making it the first treatment to combine a SGLT2 inhibitor with metformin.
Xigduo is a combination of the widely used diabetes drug metformin and dapagliflozin, a new diabetes treatment sold in Europe as Forxiga. It was approved earlier this month by the U.S. Food and Drug Administration (FDA) under the name Farxiga.
Dapagliflozin is in a new class of diabetes drugs known as SGLT2 inhibitors. Johnson & Johnson’s SGLT2 Invokana was approved in the U.S. in 2013. Other SGLT2 drugs are currently in development. The class offers a new way of treating type 2 diabetes, a chronic condition that is associated with obesity and sedentary lifestyle. Studies on SGLT2 inhibitors show that it can help patients lose weight.
Forxiga, however, has also been associated with fungal and urinary tract infections, and drug regulators have also raised concerns about the risk of bladder cancer. Ten patients who used Forxiga during clinical trials on the drug developed the disease. The risk of bladder cancer will be listed on the safety labels of Farxiga sold in the U.S. The drug makers will also have to collect long-term data on bladder cancer and cardiovascular risks.
Farxiga isn’t the only type 2 medication linked to cancer risks. The widely prescribed Actos also carries bladder cancer warnings. Studies have also shown that the diabetes drugs Januvia and Byetta have been linked to acute pancreatitis and pancreatic cancer.