The Food and Drug Administration (FDA) wants more clinical trial data on Janssen’s new type 2 diabetes treatment that combines the recently approved Invokana (canagliflozin) with the widely used metformin, before it will decide whether to approve the new combination therapy. The agency requested more information comparing the twice-daily combination pill with the once-daily canagliflozin. Janssen, a Johnson & Johnson company, says it has the data the agency needs from its comprehensive Phase 3 clinical development program for the drug.
Canagliflozin was approved by the FDA in March 2013. It is the first approved drug in a new class of medications known as SGLT2 inhibitors. The drugs work by selectively inhibiting sodium glucose co-transporter 2, a carrier responsible for the reabsorption of glucose by the kidney, allowing glucose to pass through the urine resulting in lower blood glucose levels in adults with type 2 diabetes.
Metformin is a first-line oral medication for type 2 diabetes. It works to lower blood glucose levels by decreasing the amount of glucose made by the liver.
Despite cardiovascular problems noted in clinical trials during the review of canagliflozin, the drug was ultimately approved by the FDA. Heart attacks and strokes have been seen with some diabetes medications, including Avandia, which was severely restricted by the FDA in 2010. Those restrictions were recently lifted even though the FDA says there is still some uncertainty regarding cardiovascular risks.
Other diabetes drugs have raised other serious health concerns, including cancer risks. In 2011, the FDA warned that the type 2 diabetes drug Actos had been linked to bladder cancer. More recent studies have linked the drugs Byetta and Januvia to acute pancreatitis and pancreatic cancer.
If approved, Janssen’s combination canagliflozin and metformin pill could boost the drug’s sales even further. In just three quarters, sales of canagliflozin (Invokana) have skyrocketed and it is now the number-one branded therapy prescribed by U.S. endocrinologists when adding or switching non-insulin type 2 diabetes medications.
Earlier this month an FDA advisory committee recommended the agency approve another SGLT2 inhibitor, Forxiga (dapagliflozin) made by Bristol-Myers Squibb and AstraZeneca. The FDA is not required to follow the recommendations of its advisory committees, but it usually does.
Source: Drug Discovery & Development