AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) are trying once again to get U.S. approval for their drug dapagliflozin, an innovative but potentially risky treatment for Type 2 diabetes.
The pharma giants have resubmitted to the FDA a New Drug Application for dapagliflozin, which includes several new studies and four years' worth of data from previously submitted studies.
As obesity rates in the U.S. grow, there is a significant unmet need for diabetes treatments. Nearly half of treated patients do not adequately control their glucose levels.
An investigational compound, dapagliflozin works in the kidney to selectively inhibit the sodium-glucose transport proteins (SGLT2), removing excess glucose and calories in the urine. By removing this excess glucose, dapagliflozin helps to reduce blood sugar levels. The drug works independently of insulin.
In November 2012, the European Union approved the drug under the name Forxiga--the first of its kind to gain regulatory approval. The drug is also approved to treat Type 2 diabetes in Australia, Brazil, Mexico and New Zealand. But the FDA rejected its approval in January 2012, citing concerns about patients who developed breast and bladder cancer in clinical trials and demanding that AstraZeneca and Bristol-Myers produce more data.
The FDA has long held diabetes drugs to high safety standards, but with the approval of Johnson & Johnson's ($JNJ) rival SGLT2 inhibitor in March, U.S. regulators may be warming up to the hot new class of drugs.
- here's the press release
Special Report: Dapagliflozin - Top diabetes drug pipelines of 2012