FDA Advisory Committee Recommends Approval of Afrezzar, MannKind Corporation's Investigational Drug to Treat Diabetes

MannKind Corporation has announced that the Endocrinologic and Metabolic Drugs Advisory Committee of FDA voted 13 to 1 to recommend that Afrezza (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that Afrezza be granted marketing approval by FDA to improve glycemic control in adults with type 2 diabetes. If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the US.

"We are pleased with the Advisory Committee's approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We look forward to working with FDA as they complete their evaluation of Afrezza. Diabetes is a major health problem in the US, and we are committed to bring Afrezza to the many patients who might benefit from this novel product."

FDA is not bound by the Advisory Committee's recommendation, but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for Afrezza. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of Afrezza is 15 April 2014.

www.mannkindcorp.com