MannKind reports positive diabetes drug data
MannKind Corporation has announced positive preliminary results from phase 3 clinical trials evaluating its insulin therapy, Afrezza, in patients with type 1 and 2 diabetes. Afrezza is a novel, ultra rapid-acting mealtime insulin therapy being developed for the control of hyperglycemia. The inhaled insulin device proved to be more effective than injected and oral treatments in clinical trials, and may have the potential to improve the quality of life for millions of patients with diabetes.
The US FDA rejected approval of Afrezza in 2011, stating the company needed to conduct two clinical trials to prove that the second-generation of the device was equivalent to its first-generation inhaler. The first trial, Study 171, compared Afrezza with NovoLog, Novo Nordisk’s injected insulin. The second trial, Study 175, compared Afrezza with oral therapy. Both found Afrezza to be optimum.
“We are pleased that both Phase 3 studies met their primary efficacy endpoints and that Study 171 also achieved its other main objective of demonstrating comparability between the Gen2 and MedTone inhalers. The positive results of Study 171 and Study 175 will form the basis of an amendment to our new drug application for AFREZZA, which we expect to submit to the Food and Drug Administration early in the fourth quarter of this year.”
Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation.
It’s been said that half a billion people worldwide will be diabetic by 2030. Analysts expect that Afrezza will get regulatory approval, but are wondering which partner MannKind will choose in order to successfully commercialize the product.
In morning trade following the announcement, MannKind’s shares rose as much as 27%.
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