June 29, 2014
FDA Approves Afrezza Inhalation Powder For Diabetics
April Flowers for redOrbit.com - Your Universe Online
Treatment options for diabetes come in a wide variety, ranging from oral medications to insulin pumps.
This week, the US Food and Drug Administration (FDA) approved the rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus, or Type I diabetes.
The FDA estimates that 25.8 million people in the US are affected by diabetes. This is approximately 8.3 percent of the nation's population. Serious complications, including heart disease, blindness, nerve damage and kidney damage, can result from long-term high blood sugar levels.
"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," Dr. Jean-Marc Guettier, the FDA director in charge of diabetes products evaluations, said.
The inhaler, which can also be used by Type II diabetics in conjunction with oral antidiabetic drugs, is not intended to replace long-acting insulin. Rather, it should be used in combination with long-acting insulin for Type I patients.
Over 3,000 people participated in the clinical trial — 1,026 with Type I and 1,991 with Type II.
California-based Mannkind Corporation developed rapid-acting Afrezza, which should be administered before eating, or within 20 minutes of starting a meal. According to the company, Afrezza users saw peak insulin levels within 12 to 15 minutes after administration, compared to the 45 minutes it took for injected, rapid-acting insulin users.
Although the FDA approved Afrezza, it was only with a Boxed Warning (the strongest warning type) that indicates that Afrezza should not be used in patients that already have chronic lung diseases, such as asthma, COPD and smoker's cough. The medication has been shown to cause breathing spasms in such cases. The FDA is also requiring Mannkind to perform several follow-up studies to evaluate the drug's long-term safety, including its impact on the heart and lungs.