FDA approval opens door for inhaled insulinBy
The latest innovation in diabetes treatment may involve adding another insulin delivery method to the current options of injectable insulin therapies. This week (first of April 2014), the U.S. Food and Drug Administration gave approval for a form of insulin that would be inhaled instead of injected.
Afrezza® (pronounced uh-FREZZ-uh) is an ultra-rapid-acting insulin taken at mealtime. It is combination product. It consists of an inhaled powder and single use dose cartridges that fit into a small inhaler.
Taken at the start of a meal, Afrezza dissolves and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 15 minutes of administration, mimicking the release of mealtime insulin observed in healthy individuals.
An FDA committee said Afrezza, developed by the MannKind Corporation, would be useful in some cases, even if it might not be quite as effective as injected insulin.
“As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin,” Dr. Robert J. Smith, an endocrinologist at the Alpert Medical School at Brown University and the committee’s acting chairman, said after the vote.
The Mannkind group believes Afrezza may be “a promising new therapy for patients with Type 1 and Type 2 diabetes, as it has been shown in clinical studies to control post meal-time glucose levels, cause less weight gain and have lower risk of hypoglycemia than current standard insulin therapies.”
For more on inhaled insulin, visit:
- New York Times: Inhaled Insulin Clears Hurdle Toward F.D.A. Approval
- WebMD: Inhaled Insulin Should be Approved by FDA: Panel
- MannKind Corporation: AFREZZA® – A First-in-class Ultra Rapid-Acting Insulin