The FDA has approved the inhaled human insulin product Afrezza to improve glycemic control in adults with type 1 or type 2 diabetes….
The FDA said the device offers a new treatment option for patients with type 1 diabetes. The 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 drug will carry a boxed warning, the most serious available, that acute bronchospasm has been seen in patients with asthma and chronic obstructive pulmonary disease and that it should not be used in patients with those conditions.
Afrezza is a rapid-acting inhaled insulin to be administered prior to meals or within 20 minutes of starting a meal. It is not a substitute for long-acting insulin and must be used in combination with long-acting insulin in patients with type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or who have chronic lung disease.
Efficacy and safety data came from studies involving a total of 3,017 patients, including 1,026 with type 1 and 1,991 with type 2 diabetes. At 24 weeks, Afrezza reduced HbA1c levels by the prespecified end point of 0.4 percentage points in both groups. Hemoglobin A1c reduction was inferior to that of insulin aspart among type 1 patients but significantly superior to placebo among type 2 patients who were also taking oral glucose-lowering medications.
The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
The FDA also approved Afrezza with a risk evaluation and mitigation strategy, including a communication plan to inform healthcare professionals about the serious risk for acute bronchospasm associated with the medication.
The FDA is requiring 4 postmarketing studies for Afrezza:
- A clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients.
- A clinical trial evaluating the potential risk for pulmonary malignancy with Afrezza, along with assessment of cardiovascular risk and long-term effect on pulmonary function.
- 2 pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, 1 characterizing dose-response, the other within-subject variability.
As medical professionals, you can expect a barrage of questions from patients.
The rapid-acting insulin is taken before each meal, or soon after starting to eat, with no needles required. Afrezza won’t replace the need for injected long-acting insulin for those who need it, though.
Because it is inhaled, Afrezza is absorbed more quickly, so from the time it’s inhaled to the time it actually peaks [in the blood] is 15 to 20 minutes, while injected insulin may take up to an hour to peak when taken before a meal.
The body also clears Afrezza more quickly than insulin injected at mealtime. Besides its rapid peak, the drug is ”pretty much gone in 2 or 3 hours. The rapid acting injected insulins usually are present for about 4 hours. So Afrezza is fast in and fast out, more like what the pancreas actually does.
Afrezza will come in a powder form with a small inhaler which is pocket sized and easy to train and use. Different doses come in multiple cartridges which each contain a single dose that is disposable after use.
In a 24-week study, researchers compared Afrezza with a rapid-acting, injected insulin in more than 500 patients with type 1 diabetes. Afrezza and injected insulin controlled blood sugar equally well and Afrezza seems to have less hypoglycemia due to its fast in and fast out cycle.
Due to its also being in the body less time, patients may need less insulin and this could account for less weight gain when compared to injected insulin.
In the study with type patients, researchers found that people who weren’t getting enough control with oral medications did better when they added inhaled insulin before meals.
Many doctors will most likely take a wait and see approach, as they have been burned before with new drugs coming into the market including the Exubera debacle in 2007.
The manufacturer’s expectation is that Afrezza will cost about the same as the current fast-acting injected insulins delivered in a pen form. One popular fast-acting pen insulin costs about $270 a month without insurance coverage for a person who needs 30 units a day, a common amount. Afrezza may also not be available for a while as MannKind is seeking a partner with a pharmaceutical company for distribution.
- Afrezza comes in a powder form that comes in a small inhaler
- The FDA approved Afrezza’s safety and effectiveness based on data from studies of about 3,000 people with diabetes
- It will carry a boxed warning, that acute bronchospasm has been seen in patients with asthma and chronic obstructive pulmonary disease and that it should not be used in patients with those conditions.
Reported at the ADA Scientific Sessions June, 2014: Study 171, a Phase 3 clinical study of AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation (Gen2) inhaler (also known as the Dreamboat™ inhaler), in patients with type 1 diabetes.