Pharmaceutical

Makers of inhaled insulin treatment for type 2 diabetics hope to apply for FDA approval

diabetes illus250x03 Makers of inhaled insulin treatment for type 2 diabetics hope to apply for FDA approvalAfrezza, a novel, inhaled mealtime insulin therapy showed encouraging results in reducing long-term blood sugar levels in type 2 diabetics during two late-stage clinical studies, drug developer MannKind Corp. announced last week.

Afrezza was pitted against the widely used generic metformin in type 2 diabetes patients during clinical trials, where data showed it worked better at long-term blood sugar reductions. It also performed well compared to another insulin treatment in type 1 diabetics.

Afrezza is a fast-acting insulin powder that comes in single-use cartridges. The powder is delivered through an inhaler called Dreamboat. MannKind said that changes in lung function in patients who used the Dreamboat inhaler were similar to those in patients who were using the MedTone device, another insulin inhaler.

MannKind hopes to use the data when it applies for Food and Drug Administration (FDA) approval sometime early in the fourth quarter. The agency had previously rejected Afrezza twice in 2010, saying it wanted data pitting it with MedTone.

Type 2 diabetes is a chronic disease in which the body does not make enough insulin or uses it inefficiently. It can lead to serious health complications including early death, cardiovascular disease, kidney disease, blindness, and amputations from neuropathy. Many patients require other medications to control their type 2 diabetes, and those drugs can carry serious risks.

For example, in 2011, the FDA warned that the type 2 medication Actos was linked to cases of bladder cancer. More recently, studies have shown that the drugs Byetta and Januvia can increase the risk of acute pancreatitis and pancreatic cancer.

Source: ABC News