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MannKind’s inhalable ultra-rapid-acting insulin Afrezza has its day at the FDA

In a recent article in The New England Journal of Medicine, researchers found that only 52% of people with diabetes in the US are achieving an A1c less than 7.0%, a percentage that actually worsened since the last update. The article also reported that about one in seven people with diabetes in the US has an A1c greater than 9.0%, putting them at major increased risk for complications. This is set against an important backdrop – the psychological barriers and stigma associated with taking insulin, despite its role as the most effective glucose-lowering therapy. Clearly, our available insulins and their associated delivery devices are not helping nearly as many patients as they could -- we would like to see a greater variety of diabetes therapies, and more types of insulin and delivery devices in particular, along with better trained providers, doctors and nurses who were compensated correctly (right now, putting patients on insulin is a money loser for many healthcare providers due to the time and complexity) and more empowered patients, of course.

That brings me to MannKind’s inhalable, ultra-rapid-acting insulin Afrezza, which will be the topic of an FDA Advisory Committee meeting on April 1 – tomorrow! Afrezza has the potential to be an amazing alternative for people who aren’t getting the desired results from their current insulin or are nervous about insulin injections. It would be the first inhalable insulin to appear on the market since the withdrawal of Pfizer’s Exubera in 2007 (there were a whole host of problems there, but this one promises to be quite different). The sleek, compact Afrezza inhaler is a far cry from the clunky device used to deliver Exubera. Such a discreet, hassle-free delivery is great news for people who are wary of taking insulin at work or in public.

If approved, Afrezza would also be a first in the next-generation ultra-rapid-acting insulin. MannKind’s product peaks after about 12-15 minutes, a massive improvement from the 60-90 minute range of current rapid-acting insulins like Humalog, Novolog, and Apidra. Such an ultra-rapid-acting insulin should improve control in after-meal glucose levels, and its quick peak makes Afrezza an intriguing candidate for use with artificial pancreas systems. The latest data in type 1 diabetes found that use of Afrezza at mealtime led to 42% less total hypoglycemia, a significant improvement in fasting blood glucose (-25 mg/dl with Afrezza vs. +10 mg/dl on Novolog), and about one pound of weight loss (vs. two pounds of weight gain with Novolog).

So why hasn’t Afrezza been approved already? That’s a question plenty of people – including those of us at diaTribe – have been asking for a while. This isn’t the first time that Afrezza has been considered by the FDA; MannKind previously received a Complete Response Letter in 2011 requesting additional safety data for the drug. Over the past few years, MannKind has completed multiple such safety trials, and the data look compelling. These new phase 3 trials (described in diaTribe #57) were designed to specifically address the FDA’s concerns. The FDA and its upcoming April 1 Advisory Committee would need a truly compelling reason NOT to let Afrezza move forward.

To reject Afrezza at this stage, assuming the panel agrees the drug is safe, would be a blow for patients, for MannKind, and for diabetes drug development as a whole. Assuming it is safe (we look forward to the expert opinion on safety discussed at the Advisory Committee), the failure to approve Afrezza will send a disturbing message – that the FDA is not prepared to consider risk/benefit appropriately and particularly with regard to  innovative diabetes products. I dread a future in which companies will not invest in groundbreaking ideas for fear that any such innovation would lead to a regulatory dead end. I understand that the FDA’s mandate is to place patient safety first, but sometimes that can go too far. As a patient, as long as there is good, strong evidence that a new medication is safe and effective, I am willing to take the risk in the name of improved glycemic control, better management of my diabetes, and higher quality of life. From where I’m standing, Afrezza seems well worth the risk, especially because the risk all patients take as it stands in taking insulin is bigger than it seems.

Managing Editor Adam Brown and I will be speaking as patients at the FDA Advisory Committee on April 1 – if you have any comments or recommendations, please write us and let us know. Speaking of patient advocacy, a huge thank you to the FDA, Bennet Dunlap, Strip Safely, and members of the online diabetes community for organizing and joining in the FDA's patient network live chat on diabetes and glucose monitoring devices. We thought it was a wonderful opportunity and hope it becomes a regular monthly meeting to increase communication between patients and the FDA. 

Update: We are thrilled to report that the FDA Advisory Committee has just voted overwhelmingly in favor of approving Afrezza for use in type 1 and type 2 diabetes! The diaTribe team was onsite during the meeting (you can follow our live tweeting at @diaTribeNews), and Kelly and Adam gave their speeches at the open public hearing on the importance of Afrezza for people with diabetes. Thank you to our readers who wrote in with their experiences as well as friends in the diabetes online community who spoke with us at the meeting - Bennet Dunlap of Strip Safely, Manny Hernandez of the Diabetes Hands Foundation through webcast, Dr. Steve Edelman of TCOYD, Dr. Aaron Kowalski of JDRF, Dr. Bob Ratner of the ADA, and the legendary Dr. Lois Jovanovič of Sansum Diabetes.

Although there is still a lot of work ahead to get this product to patients (product labeling, reimbursement, and access to name just a few), we are excited for the outcome today and view this as a MAJOR win for patients. 

 

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