An advisory panel of the Food and Drug Administration has recommended the approval of the use of canagliflozin, a new drug that is being developed by Johnson and Johnson, for the treatment of Type 2 diabetes. This new medication — which will be called Invokana if it is eventually approved — is unique in that it lowers blood sugar levels by causing it to be excreted in the urine. As well, patients might also experience weight loss when taking canagliflozin.
At the time of its recommendation, the panel also expressed concerns about the possible side effects of the use of canagliflozin, to include an increased risk for stroke and heart attacks in some patients and a concern for patients who have any type of kidney impairment. The vote of the panel was 10 to 5. This is a new type treatment drug for Type 2 diabetes, with the medications currently in use addressing the supply and use of insulin in the body.
The clinical trial included 10,000 patients worldwide and showed that the drug improved the blood sugar levels of the participants, weight loss and a lowering of blood pressure. The prescribed dosage would be once a day and used only for those patients with Type 2 diabetes.
Although the vote was 10 to 5 for approval, those who did vote in favor of the approval of canagliflozin expressed concerns about the serious side effects of the drug and requested that Johnson and John closely monitor patients that are enrolled in long-term safety studies. Some of the doctors on the panel stated that they did not think the drug should be used by people with moderate kidney disease. Their concern about the use in patients with moderate kidney disease was caused by the results of the study that indicated that the drug was not as effective for those patients as it was for those who had normal kidney function. The drug is not recommended for patients with severe kidney disease.
As noted previously, concerns were raised about the signs of increased risk of stroke and a small increase in patients suffering heart attacks and other cardiovascular symptoms within the first 30 days of taking canagliflozin. Canagliflozin was shown to raise the bad cholesterol levels (LDL), while at the same time raising the good levels of cholesterol (HDL).
Some panelists stated that the drug showed that it warranted approval but also stated that they hoped the Food and Drug Administration could address the concerns raised by requiring Johnson & Johnson to have appropriate warnings about the drug, if it is approved. The FDA is not required to follow the recommendations of its advisory committees, but it usually does.
Panelist patient representative, Rebecca Killion, voted in favor of the approval: “I think it particularly addresses concerns that patients have with respect to struggling with weight loss – which affects the progress of their disease – and the concern that all diabetic patients have about hypoglycemia.”
Patients in the study who received canagliflozin had fewer insulin reactions (extremely low and dangerous sugar levels) when compared to other medications, such as glimepiride (Amaryl), but a similar rate compared to patients taking sitagliptin (Januvia).
One panel member, Edward W. Gregg of the Centers for Disease Control and Prevention, who voted against the approval, stated: “In the end, I found myself weighing a lot of ‘maybe’ benefits versus a lot of ‘maybe’ risks.”
Johnson & Johnson representative Dr. Peter Stein stated that he was “gratified” that the panel voted to approve the drug and stated that Johnson & Johnson would continue to monitor patients for safety risks. “We have a strong belief that canagliflozin is a medication which really offers a new option for Type 2 diabetes patients,” Dr. Stein stated.
A drug similar to canagliflozin did not receive approval last year from the FDA because of safety concerns, to include increased risk of breast cancer and bladder cancer, but was approved in Europe recently under the name Forxiga. Forxiga is not manufactured by Johnson & Johnson.