FDA Approves New Insulin Drug That Allows Diabetic To Use Inhalers

FDA Approves New Insulin Drug That Allows Diabetic to Use Inhalers

The United States Food and Drug Administration has approved a new insulin drug that allows diabetics to put aside needles at times when they want to eat and instead use inhalers. However they are not considered substitutes for long acting insulin. Afrezza Inhalation Powder is the official name of the new drug and it is meant to be used  in combination with insulin for patients who suffer from type 1 diabetes. The FDA also stated that, that in a clinical trial that was performed, Afrezza had been shown to be effective in treating each type of diabetes. Individuals who have type 2 diabetes may use it in combination with their oral anti-diabetic drugs.

Dr. Jean-Marc Guettier, who is the FDA director in charge of diabetes products evaluations, stated that the approval of the insulin inhaler widened the the options that were open for delivering insulin at mealtime in the total management of people who have diabetes and need it to regulate their blood sugar levels. The research study involved nearly 1,030 individuals who suffered with type 1 diabetes and just over 1,990 people who had type 2 diabetes.

The inhalant is to be taken at the start of  each meal or within 20 minutes after beginning to eat. The fast acting therapy was created by a company located in California known as MannKind Corp. The company declared in a news release that top insulin levels occur within 12 to 15 minutes of taking insulin with Afrezza, in comparison to between 45 minutes and 90 minutes with rapid acting insulin that is injected with a needle.

The FDA included a boxed warning on Afrezza, which is the strongest kind. It stated that the drug should not be used in individuals who suffered from chronic lung diseases, such as asthma or smoker’s cough. This was because of reports of breathing spasms happening. The agency also wants several follow up studies performed as so to examine the drug’s long term safety. They want to watch the drug’s  impact on both the lungs and the heart, to make sure there is no permanent damage there.

There are just under 30 million people in the United States who have diabetes, states the U.S. Centers for Disease Control and Prevention or CDC. The approval on Friday came more than three years after the agency had fist wanted MannKind to start running more clinical tests on the drug.

There is a worldwide surge in demand for diabetes treatments as the epidemic of obesity goes global. The World Health Organization or WHO states that just under 350 million people the world over suffer from the disease. Diabetes is a chronic condition in which the body either does not use insulin efficiently or fails to make enough insulin to break down the sugar in foods. Such a problem can cause blindness, heart disease, strokes and ultimately death. Type 2 diabetes is the most common form of the disease. It is where the body is unable to use insulin properly. Type 1 diabetes is most often diagnosed in children and young adults. This is where the body does not produce insulin.

There have been a few other companies which tried to make inhaled insulin but failed. Both Pfizer Inc.  and Eli Lilly & Co. ended their respective programs after they neither one were able to get off the ground. Even so, the U.S. FDA has finally approved a new insulin drug that allows diabetics to put aside needles at times when they want to eat and instead use inhalers.

By Kimberly Ruble


The Wall Street Journal

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