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 has accepted AstraZeneca and Bristol-Myers Squibb's resubmission of a marketing application for dapagliflozin for treatment of type 2 diabetes. A decision is expected by Jan. 11. The sodium-glucose co-transporter 2 inhibitor has been approved for sale in Europe and is being sold in Brazil and Australia, among other nations.
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.