MannKind Corp. won U.S. approval to sell its inhaled insulin, culminating an almost decade-long effort, with a warning that the product shouldn’t be used by those with asthma or a serious lung disease.
The Food and Drug Administration said yesterday it cleared MannKind’s Afrezza as a fast-acting insulin to be used at meal times for those with Type 1 and Type 2 diabetes. The drug labeling will warn that spasms in the airways of the lung have been seen in patients with asthma and chronic obstructive pulmonary disease and will advise against smokers using the medicine, the agency said in a statement.
“It’s very gratifying,” Chief Financial Officer Matt Pfeffer said in a telephone interview. “We’ve been working toward this moment for a very long time, so we’re thrilled that it’s here.”
Alfred Mann, MannKind’s 88-year-old founder and chief executive officer, took the Valencia, California-based company public in 2004. Since MannKind started late-stage clinical trials eight years ago, the company’s share price has bounced from a high of $21.70 to a low of $1.60, Pfizer Inc. pulled the only inhaled insulin from the market and the FDA twice rejected MannKind’s therapy, most recently in 2011, after the company switched inhalers during the review process.
“It’s good news, and I consider the boxed warning to be a non-event,” Keith Markey, a New York-based analyst at Griffin Securities Inc., said in a telephone interview. “MannKind never wanted to market it to people with COPD.”
Shares of MannKind gained 10 percent to $11 in extended trading at 6:56 p.m. New York time yesterday after falling 5.5 percent during regular trading to close at $10.
An estimated 25.8 million people in the U.S. have diabetes, a condition in which insulin isn’t naturally produced or used effectively by the body to break down sugar in the blood. The illness can lead to heart disease, blindness and nerve and kidney damage.
MannKind’s drug, a powder, is delivered through a cartridge and is designed to control blood sugar during meal times in less time than standard injections. The FDA said it doesn’t replace long-acting insulin for Type 1 patients, whose bodies don’t naturally produce insulin.