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 European Medicine Agency's Committee for Medicinal Products for Human Use has endorsed the approval of 11 new treatments including cancer drugs Kadcyla from Roche Holding and Xofigo from Bayer. The list includes Otsuka Pharmaceutical and Lundbeck's Abilify Maintena, or aripiprazole, for schizophrenia; Janssen-Cilag's Invokana, or canagliflozin, for type 2 diabetes; and Gilead Sciences' Vitekta, or elvitegravir, for treatment of HIV-1.
Boehringer Ingelheim and Eli Lilly & Co. have launched an educational campaign for health care workers focused on sodium glucose co-transporters in support of empagliflozin, an SGLT2-inhibitor that the drugmakers developed. The campaign includes a website and a video.
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.