Johnson & Johnson Submits New SGLT-2 Inhibitor Canagliflozin for Approval in US
In May, Johnson & Johnson submitted its SGLT-2 inhibitor canagliflozin for approval in the US. On average, the FDA takes about ten months to review applications for new drugs, placing a possible approval date in March 2013. If approved, canagliflozin would become the first SGLT-2 inhibitor to enter the US market. Canagliflozin was also submitted for approval in Europe on June 26, putting a potential approval sometime in the middle of 2013. As a reminder, SGLT-2 inhibitors are a class of type 2 diabetes drugs that cause users to excrete excess glucose through their urine (for more details, please see learning curve in diaTribe #24). At the American Diabetes Association (ADA) meeting this month, phase 3 trial results were reported for the first time for canagliflozin. In these trials, canagliflozin provided greater reductions in A1c than several other type 2 diabetes therapies, including the DPP-4 inhibitor Januvia (sitagliptin) and the sulfonylurea glimepiride. Canagliflozin also provided greater improvements in weight and blood pressure than either drug, with a low risk for hypoglycemia. As with other SGLT-2 inhibitors, however, canagliflozin was associated with higher rates of urinary tract infections and genital infections - although these side effects caused few participants to discontinue from the trial.
The SGLT-2 inhibitor dapagliflozin (Forxiga) was denied approval by the FDA in January. While Bristol-Myers Squibb and AstraZeneca (the manufacturers of dapagliflozin) have not discussed in depth the reasons behind the FDA’s rejection, the agency is likely concerned about potentially increased risk for bladder and breast cancer as well as liver damage detected in dapagliflozin’s clinical trials (for more information, please see new now next in diaTribe #39). Whether there is an actual increased risk for these side effects remains unclear, and the data reported thus far have not suggested any increased risk for cancer or liver injury with canagliflozin. Encouragingly, dapagliflozin was recommended for approval in Europe by an initial European regulatory assessment committee in April, and a final approval decision is expected from European regulatory authorities over the next several weeks (for more information, please see new now next in diaTribe #42). —AW/BK