Individuals with diabetes may soon have the option to inhale insulin rather than to stick themselves with needles when the need for it arises.
The Inhalation Powder, developed and manufactured by MannKind, has just gotten the go-signal from the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration for marketing, and will be sold under the brand name Afrezza.
The FDA panel of advisers voted 13-1 for Afrezza to be used by individuals who need to improve glycemic control due to type 1 diabetes, and voted 14-0 for those suffering with type 2 diabetes. The action of this drug and its delivery system would be the most rapid-acting mealtime insulin therapy available in the country, if plans to market it actually push through.
Before the voting period, the panelists from the FDA extensively discussed safety issues connected with inhaled medication, specifically bronchospasm, degeneration and eventual loss of pulmonary function over time, and the risks of lung cancer. Apparently, an earlier inhaled insulin version called Exubera, once manufactured by Pfizer, has been linked with increase in lung cancer cases.
The panelists also took into consideration the impact of efficacy differences on the overall risk-benefit ratio of insulin that is inhaled compared with insulin that is injected. The panelists looked into certain patient sub-groups that might benefit from the inhalable insulin. These sub-groups include those who are afraid of needles and those with visual impairments and issues with manual dexterity, which makes it difficult for them to handle needles by themselves.
This approval has come after MannKind's third time to seek for such an approval for Afrezza as a way to improve glycemic control in individuals suffering from diabetes. In 2011, it was denied approved due to insufficient data. In 2013, approval was also denied as the FDA needed more clinical and labeling information. The third time, it seems, is truly a charm.
"Barriers that limit effective glycemic control and impeded compliance with starting/maintaining insulin therapy, such as clinical inertia, suboptimal insulin dosing and use, and fear of weight gain and hypoglycemia, contribute substantially to a patient's glycemic burden," said the Mannkind Corporation in its most recent briefing document submitted to the FDA. "Earlier initiation of insulin remains an important unmet medical need. New Insulin therapies that provide convenience, ease of use, and clinical benefit could be important additional therapeutic options for individualized DM management."
Diabetes is a chronic condition that requires regular injections of insulin in order to normalize digestion and blood sugar levels. The American Diabetes Association says that over 25 million American children and adults suffer from diabetes now. Of this number, five percent have type 1 diabetes, in which the body does not have the capacity to make the insulin it needs. The rest are suffering from type 2 diabetes, an acquired condition that results from overeating, lack of exercise, and an unhealthy diet, and occurs when the body gradually stops responding to insulin.