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Mannkind Studies Show No Increased Risk of Cardiac Events in Diabetes Patients Treated with AFREZZA

MannKind (NASDAQ: MNKD) annouces that the findings of two separate studies further substantiate that treatment with the investigational ultra rapid acting mealtime insulin AFREZZA (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events in type 1 or type 2 diabetes patients. Furthermore, results demonstrate that inhaled AFREZZA did not produce clinically significant effects on heart rate, PR and QRS interval duration, or cardiac morphology. The data are being presented at the American Diabetes Association's 71st Scientific Sessions.

AFREZZA® is a novel, ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia. Two phase 3, multicenter clinical trials are currently underway to evaluate the efficacy and safety of AFREZZA using MannKind Corporation's next generation inhalation device.

“In response to the recent concern over the cardiovascular risk of diabetes therapies, it is important to carefully analyze all trials and maintain an ongoing program of safety surveillance,” said Anders H. Boss, M.D., M.F.P.M., Senior Vice President and Chief Medical Officer at MannKind Corporation. “These most recent safety findings add to the growing body of evidence that AFREZZA may be a promising new therapy for patients with type 1 and type 2 diabetes, without the concern of increased risk for cardiovascular events.”

Posted-In: News FDA

 

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