Mannkind says it has resubmitted a once-rejected new drug application to the U.S. Food and Drug Administration for its inhaled insulin-and-inhaler combination, Afrezza, securing a promise of agency action on the drug by the end of 2010.

The FDA issued a complete response letter to the company on March 15 in which it asked for additional data supporting the clinical utility of Afrezza. It also wanted information about how Mannkind's first inhaler, the MedTone, compared to a different version of the Afrezza inhaler used in a pivotal clinical trial, the company's next-generation “Dreamboat” model.

MannKind responded by offering the FDA clinical data from a recently completed efficacy study in patients with Type 1 diabetes as well as updated pooled safety data related to Afrezza, it says. The company also included information about its Dreamboat inhaler.

“We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA,” says Alfred Mann, Mannkind's CEO and chairman.

Although the FDA’s acceptance of Mannkind’s revised application has no bearing on whether Afrezza will ultimately achieve approval, it is an “incremental positive,” says Rodman & Renshaw analyst Simos Simeonidis, in a recent client note. Without access to the content of the complete response letter, some investors had feared that the FDA might have asked Mannkind to conduct lengthy new clinical trials before it would accept a revised application for Afrezza. The company's relatively rapid resubmission of its application dispels that fear, Simeonidis says.

Afrezza is a powdered insulin for helping adult patients with type 1 and type 2 diabetes mellitus control high blood glucose, also known as hyperglycemia, which is a major cause of diabetes-related complications. An FDA decision on the drug was initially expected by January 16. The agency's new Prescription Drug User Fee Act action date for Afrezza is December 29.