FDA Approved New Diabetes Drug Afrezza
The United States Food and Drug Administration (FDA) has approved a new kind of drug for type 1 or type 2 diabetes. The drug called Afrezza manufactured by MannKind Coorporation of Danbury, CT will be the nation's first available inhalable insulin medication.
"[Afrezza] is a new treatment option for patients with diabetes requiring mealtime insulin," Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said reported by Philly. "[It] broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels."
The FDA made their decision after reviewing a study that involved around 1,000 people diagnosed with type 1 diabetes and another 2,000 people with type 2 diabetes. In type 1 diabetics, the researchers compared the effectiveness of taking Afrezza as opposed to aspart, which is a fast-acting insulin. Both drugs were taken in combination with a long-acting insulin called basal insulin. After six months, the researchers found that the Afrezza combination was more effective in controlling blood sugar levels.
For people with type 2 diabetes, the researchers looked at the effectiveness of taking Afrezza with diabetes pills and diabetes pill with a placebo. During the six month mark, the researchers concluded that the Afreeza combination yielded better results than the other drug combination. The FDA stated that Afreeza should ideally be used in combination with long-acting insulin. The medicine alone cannot help manage blood sugar levels.
The most common side effects of inhaling the drug were low blood sugar, also known as hypoglycemia, cough and throat irritation or pain. Smokers and people with diabetic ketoacidosis or lung problems should not use Afreeza. The product will carry a warning label regarding the dangers of taking the drug with diseases such as COPD (chronic obstructive pulmonary disease) and asthma.
Despite the approval, the agency has also ordered "post-marketing studies" that will look into the effects of Afrezza on children. These studies will also examine the link between the drug and lung cancer risk.