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Millions of diabetics across the globe who are using injectable insulin before meals are likely to be benefited by this. The US Food and Drug Administration (USFDA) last week approved Afrezza inhalation powder, a rapid acting inhaled insulin for glycemic control in adults with diabetes.
A product of MannKind Corporation, Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. Director of the division of metabolism and endocrinology products in USFDA’s centre for drug evaluation and research, Jean-March Guettier, said, "Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin."
This approval 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 official added.
The drug’s safety and effectiveness were evaluated in a total of 3,017 participants–1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. It was found that the drug could effectively manage blood sugar.
USFDA, however, did not recommend inhaled insulin for patients of asthma and lung disease, and also smokers.
Caution in use
The manufacturers have said that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia (sudden and high decrease in blood sugar level), cough, and throat pain or irritation.
The manufaturers also highlighted the fact that Afrezza is not a substitute for long-acting insulin administered through injection. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes. This way a patient used a combination of drugs to control diabetes and would not need to take injections before every meal.
According to World Health Organisation (WHO), around 347 million people worldwide have diabetes and more than 80 per cent of diabetes deaths occur in low- and middle-income countries. WHO projects that diabetes will be the seventh leading cause of death in 2030.