FDA approvals

FDA approves Afrezza inhaled insulin for adults with diabetes

The FDA today approved Afrezza inhalation powder to improve glycemic control in adults with diabetes.

Afrezza (MannKind Corporation) is an inhaled insulin administered at the beginning of each meal.

“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in a press release. “Today’s 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.”

A study that included 3,017 participants evaluated the safety and efficacy of Afrezza among adults with type 1 or type 2 diabetes. Afrezza was compared to a mealtime insulin aspart among 1,026 adults with type 1 diabetes. Both were administered in combination with basal insulin. At 24 weeks, Afrezza plus basal insulin had a mean reduction in HbA1c that met the pre-specified non-inferiority margin of 0.4%. Afrezza reduced HbA1c significantly less than insulin aspart.

Afrezza was also assessed in combination with oral anti-diabetic drugs was compared to placebo among 1,991 adults with type 2 diabetes. At 24 weeks, Afrezza plus oral anti-diabetic drugs had a mean reduction in HbA1c that was significantly greater than HbA1c reduction among those receiving placebo.

Afrezza is not a substitute for long-acting insulin, according to the release. For use among adults with type 1 diabetes, Afrezza must be used in combination with long-acting insulin.

Afrezza displays a Boxed Warning that acute bronchospasm have been observed in patients with asthma and chronic obstructive pulmonary disease; due to this risk, Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD.

The most commonly reported adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough and throat pain or irritation.

The FDA today approved Afrezza inhalation powder to improve glycemic control in adults with diabetes.

Afrezza (MannKind Corporation) is an inhaled insulin administered at the beginning of each meal.

“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in a press release. “Today’s 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.”

A study that included 3,017 participants evaluated the safety and efficacy of Afrezza among adults with type 1 or type 2 diabetes. Afrezza was compared to a mealtime insulin aspart among 1,026 adults with type 1 diabetes. Both were administered in combination with basal insulin. At 24 weeks, Afrezza plus basal insulin had a mean reduction in HbA1c that met the pre-specified non-inferiority margin of 0.4%. Afrezza reduced HbA1c significantly less than insulin aspart.

Afrezza was also assessed in combination with oral anti-diabetic drugs was compared to placebo among 1,991 adults with type 2 diabetes. At 24 weeks, Afrezza plus oral anti-diabetic drugs had a mean reduction in HbA1c that was significantly greater than HbA1c reduction among those receiving placebo.

Afrezza is not a substitute for long-acting insulin, according to the release. For use among adults with type 1 diabetes, Afrezza must be used in combination with long-acting insulin.

Afrezza displays a Boxed Warning that acute bronchospasm have been observed in patients with asthma and chronic obstructive pulmonary disease; due to this risk, Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD.

The most commonly reported adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough and throat pain or irritation.