MannKind asks for approval of inhaled insulin
VALENCIA, Calif. (AP) — MannKind said Monday it again filed for marketing approval of its inhaled diabetes drug Afrezza, two years after regulators nixed a similar application.
Afrezza is a fast-acting insulin powder that comes in single-use cartridges delivered through an inhaler named Dreamboat. MannKind's new filing includes data from two successful late-stage trials. One involved patients with type 1 diabetes and another focused on type 2 diabetes patients.
Shares of MannKind Corp. closed at $5.11 Friday and rose 15 cents, or 3 percent, to $5.26 in premarket trading.
MannKind has no drugs on the market. It first filed for Food and Drug Administration approval of Afrezza in March 2009, and in early 2011 the FDA told the company to run more clinical studies. The agency wanted MannKind to use the studies to compare its new inhaler with an older inhaler that was used in previous studies. In August, MannKind said drug met its goals in both trials
Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can cause early death or serious complications like blindness, a stroke, kidney disease or heart disease when blood sugar climbs too high and damages organs and blood vessels.
Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Demand for drugs that treat diabetes is climbing as rising instances of obesity are linked with an explosion of diabetes cases globally.
Several other companies have failed to make inhaled insulin work commercially. Pfizer Inc. discontinued an inhaled insulin called Exubera in 2007 because of low sales, and in 2008, Eli Lilly and Co. ended its development program because it was not sure it would be able to get a drug approved.