FDA – The U.S. Food and Drug Administration approved a new form of insulin that can be inhaled rather than injected. Called Afrezza, the drug is a dry powder that diabetes patients can breathe in using an insulin inhaler.
The powder is not meant to be an alternative to insulin injections for patients with diabetes, but is supposed to be used at meal times. Afrezza has a short-term impact, and will kick in after only 12 to 15 minutes, said MannKind Corporation, the makers of the new drug.
“Approval of Afrezza is an important milestone for MannKind, as today’s FDA action validates the years of clinical research and commitment that powered the development of this unique therapy,” said Alfred Mann, Chief Executive Officer, MannKind Corporation. “We are excited for patients, as we believe that Afrezza’s distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the Afrezza clinical program.”
Afrezza is only the second inhaled insulin to ever get FDA approval. The first came out in 2006 and was called Exubera, but was pulled from the market after only one year due to the high cost to make it and the refusal of insurance companies to cover it. Pfizer, the company that produced Exubera, ultimately lost a whopping $2.8 billion on their failed product.
Hopefully, MannKind will not run into this issue with their new product. Already, doctors and healthcare specialists are talking about Afrezza and its many possible benefits.
“The FDA approval of Afrezza provides healthcare professionals with an important new safe and effective treatment option for patients with diabetes,” said Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine. “We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes Afrezza a welcome alternative for many patients who require insulin.”
The FDA’s approval of the drug does come with some stipulations, however. MannKind must provide more research on the impact of Afrezza on children, on the heart, and on the body in a long-term setting. The company must also sell the drug with a label that provides a warning to patients with asthma and COPD.