Valencia-based MannKind Corp. announced Monday that it is again asking the federal Food and Drug Administration to approve the marketing and sale of inhalable insulin powder under the name Afrezza – two years after the FDA denied the company’s initial application.
MannKind said in a statement that it filed the paperwork Sunday.
It says Afrezza is designed to improve glycemic control in adults with type-1 or type-2 diabetes.
MannKind has been in the research and development phase since it was formed by billionaire investor Alfred Mann. The company does not yet have any marketable product.
In denying the application two years ago, the FDA said more clinical trials were necessary to demonstrate the drug’s safety and efficacy. With the denial, the company’s share prices, which had hovered around the $10 level, tanked. They’ve inched up to the neighborhood of $5 in recent months, thanks largely to additional financing arranged by Al Mann. Share prices rose about 4 percent on Monday’s news, to $5.29.
The additional trials have been completed and MannKind says it’s ready to go.
“The resubmission is based on the entire data set from the extensive Afrezza clinical development program and particularly the positive results from two recent Phase 3 trials, one in patients with type-1 diabetes … and one in patients with type-2 diabetes,” the statement said.
“We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives,” CEO Alfred Mann said. “I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with the FDA to bring AFREZZA to market for the millions of diabetes patients in the United States who might benefit from this novel product.”
Afrezza (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation 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.
About MannKind Corp.
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, Afrezza, has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com.