Mannkind Phase 3 Data Shows Sustained Glycemic Control Print E-mail
By Staff and Wire Reports   
Friday, 02 October 2009 09:09

Some of the 23.6 million people in the U.S. who are affected by diabetes may be interested in hearing this news. AFRESA Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

According to the company, the results from the open-label, controlled study conducted with patients who had previously completed two three-month, randomized phase 2 clinical trials showed minimal mean change in forced expiratory volume in one second (FEV1) over a four-year period for those treated with AFRESA. Additionally, patients using AFRESA therapy experienced glycemic control for at least four years.

"We are encouraged by this long-term study which demonstrates that over four years, AFRESA maintained glycemic control with changes in lung function comparable to that seen in diabetic patients treated with injectable and oral therapies," said Peter Richardson, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. "These findings add to the growing body of clinical evidence that AFRESA is a promising therapeutic option for this patient population."

AFRESA is a novel, ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase 2/3 clinical program, a New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) requesting approval to market AFRESA Inhalation Powder and the AFRESA Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by oral inhalation.

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