FDA approval is recommended for inhaled insulin, combo drug

Action may expand options for patients with diabetes, but safety questions remain.

By Victoria Stagg Elliott, AMNews staff. Oct. 10, 2005.

Physicians are one step closer to being able to prescribe insulin that does not require a needle to be administered and to having a diabetes drug that addresses both blood sugar and cardiovascular risk factors.

The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee recommended in September that Exubera, an insulin powder for inhalation, be approved by the agency for adults with either type 1 or type 2 diabetes. The panel also gave its nod to the first drug that works on both the alpha and gamma peroxisome proliferator-activated receptors. The drug, muraglitazar (Pargluva) has been shown to reduce blood sugar and increase triglycerides among those with type 2.

"The majority of the committee felt they were safe and effective," said Paul Woolf, MD, a committee member and chair of the Dept. of Medicine at Crozer Chester Medical Center in Upland, Pa.

The FDA is not obligated to follow its advisory committee's recommendations but usually does.

Physicians who treat diabetics praised the panel's decisions.

Some anticipate that approval of an inhaled insulin will give needle-fatigued patients a break and make it easier for them to maintain intensive control. It also could increase the number of type 2 patients who initiate insulin therapy at earlier points in the disease's course.

"It's an exciting development," said Nathaniel Clark, MD, national vice president for clinical affairs for the American Diabetes Assn. "Patients are not receiving insulin because of an issue of taking injections, which is a major barrier."