The U.S. Food and Drug Administration (FDA) approved AFREZZA, an Inhalation Powder to enhance the glycemic control of adult patients suffering from diabetes mellitus, drug manufacturer MannKind Corporation said in a statement on June 27.
The FDA approval comes over three years since it initially asked the drug manufacturer to run more clinical tests on said drug.
AFREZZA is delivered through the use of a small inhaler that is easy to use. It is taken during the start of any meal and is dissolved fast after inhaling the powder deep into the lung, quickly delivering insulin to the bloodstream. Peak levels of the insulin are reached within 12 to 15 minutes of inhaling and go down the standard by around 180 minutes.
MannKind CEO Alfred Mann, 88, said that the FDA approval is a significant milestone for the company, validating the years invested in clinical research to strengthen the development of the therapy.
"We are excited for patients, as we believe that AFREZZA's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program,” said Mann.
Research says Mann invested much of his wealth to develop the innovative delivery system for AFREZZA.
Meanwhile, Janet McGill, M.D., medicine professor at the Washington University School of Medicine, said the approval provides a significantly new and efficient treatment alternative for diabetes-stricken patents.
"We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes AFREZZA a welcome alternative for many patients who require insulin,” McGill said in a statement.
Based on data from the Centers for Disease Control and Prevention, 29.1 million people in the U.S. currently suffer from diabetes mellitus, a health condition that disables the body to properly regulate blood glucose levels. The World Health Organization also said an estimate of 347 million people around the world suffer from the chronic condition.
Those who suffer such condition do not have enough insulin, a hormone that is formed by the pancreas, which controls the blood glucose levels of the body. In other cases, their bodies don’t respond properly to the produced insulin. This can bring about stroke, blindness, heart disease or death.
Current insulin treatments for diabetes mellitus being injected to patients are absorbed slower into the bloodstream as opposed to when the insulin of the body gets released if the pancreas were healthy.
Aside from AFREZZA by MannKind, many other companies produced inhaled insulin, such as Pfizer and Eli Lilly & Co., but failed to make its products gain commercial success.