Johnson & Johnson didn't disappoint close observers of the diabetes drug development field with its battery of late-stage results for the experimental diabetes drug canagliflozin. The treatment edged out two standard treatments at the high dose by reducing blood sugar to a safe range needed to avoid the seriously debilitating long-term effects of the disease. But analysts couldn't keep from fretting about the potential side effects of the therapy, which will have to clear a very high regulatory bar on safety before any approval.
Blasting out data from 5 Phase III studies, investigators for J&J ($JNJ)--which has already filed for approval on a drug that could become its first diabetes therapy--demonstrated that the 300 mg dose trimmed A1C by a full point, diving down to 6.8%. That study focused on patients whose blood glucose was not controlled by metformin and compared its results to patients given glimepiride, a standard second-line treatment. In a separate trial canagliflozin outperformed Januvia (sitagliptin), cutting A1C by a full point compared to .66% among Januvia patients. Both groups had an average A1C of 8.1% and had failed both metformin and glimepiride.
Just as importantly, the canagliflozin group experienced some weight loss with fewer episodes of hypoglycemia and there was a small tilt in its favor in reduced blood pressure.
Genital infections and a relatively higher rate of frequent urination, though, kept some analysts from calling the data an unqualified success. Canagliflozin is an SGLT2 inhibitor, a new class of diabetes drugs that is designed to control blood sugar by excreting more glucose in urine. An attempt last summer by AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) to gain an approval for dapagliflozin, another SGLT2 drug, ran into a brick wall when regulators and experts demanded more insight on the incidents of bladder and breast cancer that afflicted patients taking that drug.
The canagliflozin data released at the ADA scientific meeting over the weekend did not turn up signs of cancer. Nevertheless, you can expect the FDA to go over J&J's data with a fine-toothed comb.
"The results in each of these studies suggest that canagliflozin could provide an effective therapeutic option for adults with Type 2 diabetes in a range of clinical settings," said Kirk Ways, M.D., Ph.D., Janssen's team leader on the project. "Canagliflozin has the potential to be administered as monotherapy in patients who are inadequately controlled with diet and exercise alone, as an add-on therapy in patients being treated with metformin alone or in combination with sulfonylureas, and in patients with moderate renal impairment."
Novo's degludec reduces risk of night-time hypoglycemia
Preparing to launch an effort to grab market share from Sanofi's blockbuster Lantus, Novo Nordisk ($NVO) has unveiled new data that demonstrates degludec performed better than Lantus at reducing the risk of night-time hypoglycemia, when blood sugar levels plunge. Novo says that its experimental degludec reduced nocturnal hypoglycemia 36% compared with Lantus.
The FDA has tacked on an additional three months to its review of degludec, which was filed for an approval last fall. Novo says the agency has asked for additional data clarification and analyses before it issues a decision by Oct. 29.
"Nocturnal, or night-time, hypoglycemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect," said Bernard Zinman, lead author and director of the diabetes center at Mount Sinai Hospital, and professor of medicine, University of Toronto.
BMS, Astra release more PhIII data on dapagliflozin
Bristol-Myers Squibb and AstraZeneca have released new late-stage data on dapagliflozin, their SGLT2 inhibitor which was rejected by regulators in January.
Investigators said a 10 mg dose "demonstrated significant reductions in blood sugar levels compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with Type 2 diabetes. The results were maintained over a 24-week extension and similar results were observed when the data were stratified by background therapy."
Dapagliflozin is currently under review in Europe.
- here's the press release