Afrezza: Read the FDA Label!

MannKind Corp’s (MNKD-$10.32) inhaled insulin treatment Afrezza has been unable to outrun the long shadow of doubt cast by Exubera, the inhaled insulin device voluntarily withdrawn in October 2007 by Pfizer (due to disappointing sales). The commercial failure of Exubera should not signal defeat for MannKind’s efforts to deliver insulin via the lungs, as there are significant differences between the two products, including (i) size of Afrezza delivery device is significantly smaller; (ii) dosing — Pfizer erred in marking Exubera insulin doses in milligrams instead of units; and, (iii) dearth of formulary and managed care acceptance.

If approved, it is what is put on the drug label, often referred to as the package insert, that will likely decide the success or failure for Afrezza. Read More….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.