Study finds AFREZZA comparable to standard of care insulin therapy

MannKind CorporationApr 24 2010

Pulmonary function test results (PFTs) in patients treated with AFREZZA^TM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19^th Annual Meeting (Poster #267). Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of AFREZZA in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

“We are encouraged by these PFT data, which support our belief that AFREZZA, clinically shown to provide glycemic control similar to standard therapy with less risk of hypoglycemia and weight gain, is a promising new option that may address a poorly-met need in diabetes treatment.”

"Our findings add to the growing body of clinical evidence that indicates AFREZZA is comparable to standard of care insulin therapy in terms of lung safety," said Peter Richardson, MRCP, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. "We are encouraged by these PFT data, which support our belief that AFREZZA, clinically shown to provide glycemic control similar to standard therapy with less risk of hypoglycemia and weight gain, is a promising new option that may address a poorly-met need in diabetes treatment."

Diabetes, which affects 26.8 million people in the U.S., is characterized by the body's inability to properly regulate levels of blood glucose, or blood sugar. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes insufficient levels of insulin are produced (Type 1 diabetes) or the body fails to respond adequately to the insulin it produces (Type 2 diabetes). Historically, mealtime insulin therapy regimens have had a number of limitations, including the risk of severe hypoglycemia, the likelihood of weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and the need for injections. Additionally, therapies have not mimicked the natural time-action profile of insulin normally seen in healthy individuals and presented challenges in maintaining compliance.