MannKind: FDA Extends PDUFA Date For Afrezza By Three Months To July 15

(RTTNews) - MannKind Corp. (MNKD) announced Monday that the U.S. Food and Drug Administration or FDA has extended the Prescription Drug User Fee Act or PDUFA date for Afrezza by three months to July 15, 2014 in order to provide time for a full review of information submitted by the company in response to the FDA's requests.

Afrezza (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of Afrezza Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.

In January, MannKind had said that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration or FDA is tentatively scheduled on April 1, 2014 to review the company's New Drug Application or NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder.

The company had said it resubmitted the NDA on October 13, 2013 seeking approval to market Afrezza in the United States with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. Previously, the target date for the FDA to complete its review of the Afrezza NDA was April 15, 2014.