European drug regulators have approved Eli Lilly and Boehringer Ingelheim’s new Type 2 diabetes drug epagliflozin, which will be marketed under the brand name Jardiance.
The once-daily tablet is designed to reduce blood sugar levels by blocking glucose reabsorption in the kidneys and remove excess glucose through the urine. Unlike other diabetes treatments, Jardiance does not rely on a patient’s insulin levels in order to be effective.
Jardiance is in a class of Type 2 diabetes drugs known as sodium glucose co-transporter 2 (SGLT-2) inhibitors. Other drugs in this class include Canagliflozin, which was the first in the class to be approved in the United States, and Dapagliflozin, which was rejected by the U.S. Food and Drug Administration (FDA) but approved in Europe.
In March, the FDA rejected Jardiance, saying Boehringer Ingelheim must first fix deficiencies at one of its manufacturing plants.
Earlier this month, AdverseEvents (AE), a company that analyzes post-market side effects data, warned that newer type 2 diabetes drugs, including SGLT-2 inhibitors, as well as GLP-1 agonists and DPP-4 inhibitors, were associated with serious side effects including increased cancer and infection risks. While SGLT-2 drugs are still too new for the group to establish adverse event trends, the drugs were linked to urinary tract infections, which raised bladder cancer risks.
GLP-1 and DPP-4 drugs, such as Byetta and Januvia, were linked to a painful inflammation of the pancreas known as acute pancreatitis and pancreatic cancer.