MannKind Corporation: FDA on Afrezza

MannKind corporation

MannKind corporation will be facing an independent panel of experts and the U.S. Food and Drug Administration (FDA) on Tuesday, April 1, regarding the safety issue and efficacy of its product Afrezza. Last Friday, the company’s shares rose to 10.6 percent before falling down to 3.3 percent at $5.03 after the FDA raised red flags concerning the inhalable insulin device, which could limit its usage to specific patients. The expert panel will suggest whether the FDA should approve or reject the device.

Afrezza is a whistle-like inhaler that is designed to deliver a faster and more effective type of insulin than the current injectable version. It delivers insulin in a powdered form to type I and type II diabetics through their lungs in which it is absorbed into the bloodstream. Afrezza is meant to be taken before a meal and requires no piercing of the skin, thus, changing the way diabetics take in insulin. Despite it’s clever design, the committee is concerned about its usage among patients with bronchial spasms, pulmonary function dysfunction, and potential underlying lung diseases as well as its dosage amount administration and accuracy in MannKind’s clinical studies. Some patients who had use Afrezza suffered from similar symptoms akin to asthma and severe coughing. If the product is approved, the FDA will require that a warning label to be put on the device that limits its usage among asthma patients, smokers, and those with liver or kidney problems.

MannKind corporation had previously submitted a new drug application to the FDA for Afrezza on March 16, 2009 , seeking approval that the device can “improve glycemic control in adult patients with type 2 diabetes mellitus and type 1 diabetes mellitus.” However, the FDA rejected the insulin device in early 2011, and MannKind was required to perform two more clinical trials — one for type I diabetes and one for type II diabetes. MannKind needs to prove that a second-generation version of the inhaler, called Dreamboat, was just as effective as the first-generation one called MedTone.

Afrezza is not the first inhaled insulin device that had a poor reputation. In 2006, the FDA had approved Exubera, a similar device that was developed by Pfizer that was expected to garner $2 billion in annual sales. However, the inhaler was cumbersome and patients were not satisfied by the frequent need of lung function tests. Therefore, sales was a flop and Pfizer ditched the product. Some clinical trial showed a possibility that patients who used Exubera could develop lung cancer; however, the claim was not proven. MannKind corporation had experienced something similar when a review from the FDA of Afrezza revealed four cases of lung cancer in the product’s initial program. Patients in two of those cases had a previous history of heavy smoking and tobacco use. Dr. Lee Pai-Scherf, who is one of the staff of the FDA’s oncology products division, stated that the evidence did not provide a “meaningful analysis” because the number of lung cancer cases among the patients who took Afrezza was too small — not to mention other “confounding factors.

MannKind corporation will be facing one of its toughest challenges on April 1, and the future of the company and Afrezza rests on the approval of the FDA. For now, investors who are still rooting for MannKind can expect it to stay afloat or sink next month.

By Nick Ng


San Fernando Valley Business Journal
FOX Business