These days, drugs to treat diabetes have one of the highest safety standards to clear before they are granted approval by the Food and Drug Administration (FDA). Placebo-controlled studies are no longer enough to sway agency decision makers. Drug companies must prove their new diabetes treatments won’t cause more problems than the condition they are treating.
Which is why excitement over promising data from phase II studies on LY2605541, a joint effort by Eli Lilly and Boehringer Ingelheim, is contained. The drug showed better or equal glycemic control for patients with type 1 or type 2 diabetes than other similar diabetes medications. Patients taking the drug also reported significant weight loss compared to its anticipated competitor, Lantus. Lantus, made by Sanofi, is a blockbuster diabetes treatment, topping more than $1 billion in sales.
Just as important is the drug’s safety profile. Early data on LY2605541 shows it has a higher overall rate of hypoglycemia as well as higher levels of triglycerides than Lantus. Sanofi has also raised the safety bar by presenting new data that indicates Lantus does not raise the risk of cancer or cardiovascular disease. The findings come from a major study of 12,500 people followed over six years.
The FDA stiffened its guidelines on safety for diabetes drugs after two popular type 2 diabetes medications were singled out by the agency for associated serious risks. Avandia was severely restricted by the agency after studies linked the treatment to fatal heart attacks. The agency also issued a warning that Actos has been linked to cases of bladder cancer, especially in patients who used the drug for 12 months or longer.
Source: Fierce Biotech