The FDA said it will add warnings to labels of sodium-glucose cotransporter-2 inhibitors used to manage type 2 diabetes to indicate the risk of ketoacidosis and urinary tract infections. The agency said physicians should evaluate patients on the medications for symptoms of UTI or ketoacidosis and teach them to recognize symptoms.
Japanese regulators granted Astellas Pharma and Kotobuki Pharmaceutical approval to market their jointly developed drug ipragliflozin as a treatment for type 2 diabetes. The approval makes ipragliflozin the first sodium-glucose cotransporter 2 cleared for this indication in Japan. The drug will be sold as Suglat in 25- and 50-milligram doses.
Bristol-Myers Squibb and AstraZeneca obtained federal approval for dapagliflozin to be used in the treatment of type 2 diabetes. The drug, a sodium-glucose cotransporter 2 inhibitor, will be marketed as Farxiga. The approval requires post-marketing studies by the manufacturer to determine risks related to the drug.
The FDA approved Johnson & Johnson's Invokana, or canagliflozin, as an adjunct therapy to diet and exercise in adults with type 2 diabetes. The drug, from J&J unit Janssen Pharmaceuticals, is the first sodium-glucose co-transporter 2 inhibitor approved for diabetes. The approval was based on data from nine late-stage studies that showed improvements in hemoglobin A1c levels and fasting blood sugar levels.
Boehringer Ingelheim and Eli Lilly and Co. filed a new drug application with the FDA for empagliflozin, a sodium-glucose co-transporter 2 inhibitor, as a treatment for type 2 diabetes. The drug prevents glucose reabsorption in the kidneys and removes excess glucose via the urine.