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VALENCIA, Calif., June 27, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food & Drug Administration (FDA) has approved AFREZZA
® (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes mellitus.
"Approval of AFREZZA is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," said Alfred Mann, Chief Executive Officer, MannKind Corporation. "We are excited for patients, as we believe that AFREZZA's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program."
Currently, diabetes mellitus affects 29.1 million people in the United States, according to the Centers for Disease Control and Prevention. Diabetes mellitus is characterized by the body's inability to regulate levels of blood glucose properly. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes mellitus insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces. In patients with diabetes, current injected insulins are absorbed into the bloodstream slower than the body's own insulin would be released if the pancreas was healthy.
® (uh-FREZZ-uh) is a novel, rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. The product consists of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA dissolves rapidly 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, and decline to baseline by approximately 180 minutes.
"The FDA approval of AFREZZA provides healthcare professionals with an important new safe and effective treatment option for patients with diabetes," said Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine
. "We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes AFREZZA a welcome alternative for many patients who require insulin."
LIMITATIONS OF USE: AFREZZA must be used in combination with a long-acting insulin in patients with type 1 diabetes mellitus. AFREZZA is not recommended for the treatment of diabetic ketoacidosis and is not recommended for patients who smoke.
Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use will soon be available at
www.afrezza.com . Prior to the label being posted online, a copy of the label may be requested from the MannKind Media contacts listed at the end of this document.
AFREZZA has been approved with a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA to ensure that the benefits of AFREZZA outweigh the potential risk of acute bronchospasm in patients with chronic lung disease.