MannKind, the maker of a new, more potent form of inhalable insulin, says clinical data shows the product is safe to the lungs, according to a report from Reuters. The drugmaker says that the product (Afreeza) does not produce any meaningful, long-term changes to the lung function.
In addition, the company, announcing the results of a two-year Phase III clinical study at a Boston meeting of the American Association of Clinical Endocrinologists, said that people taking the inhaled insulin lost weight and showed fewer incidents or hypoglycemia, or low blood sugar.
Those taking Afrezza showed 0.29 percentage point reduction in A1C test scores, while those in traditional insulin therapy group showed a 0.31 percentage point drop in score. A1C tests measure the blood sugar levels over a period of several months. People with Type 1 diabetes do not produce insulin and therefore must supply the body with the hormone in order to regulate the level of sugar in the blood.
The company said in a statement 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.”
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[...] Earlier this year the regulator asked Mannkind for additional information and the company responded by submitting clinical data on the effectiveness of the drug on Type 1 diabetics from a study. It also submitted additional safety data. (See MannKind Touts Effectiveness, Safety of New Inhalable Insulin) [...]