FDA Reviews MannKind Diabetes Device
TheU.S. Food and Drug Administration is reviewing MannKind Corp’s experimental insulin device Afrezza following questions concerning the device’s safety and effectiveness.
The company’s shares rose as much as 10.6 percent before falling back amid conflicting opinion from analysts on how the FDA will likely rule.
Questions about Dosing and Missing Data
Afrezza is a whistle-sized inhaler designed to deliver more effective, rapid-acting insulin than the injectable products offered by Eli Lilly and Co and Denmark’s Novo Nordisk.
The FDA staff raised question about dosing, missing data, constriction of the air passages of the lung and Afrezza’s effect on lung function.
Simos Simeonidis, an analyst at Cowen and Company, said that due to these concerns “the drug is unlikely to win approval for Type 1 diabetes and that winning approval for Type 2 is ‘a stretch’”
The Dreamboat inhaler, an earlier generation model of Afrezza, was effective in lowering HbA1c, a measure of blood sugar, compared with a placebo in patients with Type 2 diabetes. The results are less revealing in patients with Type 1 diabetes.
The FDA’s review of Afrezza clinical trial data found four cases of lung cancer during the development program. In two of those cases the patients had a prior history of smoking, the other two did not. Dr. Lee Pai-Scherf of the FDA’s oncology products division, “the available characteristics are consistent with what would be expected in this population.”
- Patients with diabetes do not produce enough insulin for their body to use effectively. As a result, excess glucose builds up in the blood.
- Symptoms can include increased thirst, hunger, fatigue, weight loss and infections.
- If left uncontrolled, it can lead to kidney failure, blindness, heart disease and stroke.