MannKind Corporation
MNKD today announced that the Endocrinologic and Metabolic Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 13 to
1 to recommend that AFREZZA^® (insulin human [rDNA origin]) Inhalation Powder
be granted marketing approval by the 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 the 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 United States.
"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 the FDA as they complete their evaluation of
AFREZZA. Diabetes is a major health problem in the United States, and we are
committed to bring AFREZZA to the many patients who might benefit from this
novel product."
The 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 April 15, 2014.
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