Advocate for Afrezza

Appeal to FDA

This was the campaign before the news of FDA Approval of Afrezza on June 27, 2014

Wednesday, April 9, 2014

Open Letter to the FDA Listing the Benefits of Afrezza – Letter Campaign to The FDA
Please feel free to use this open letter when writing a letter or an email to the FDA. I want to encourage all to write one in your own words. You can use some of the main points in your letters that are listed below. The letter was written by someone who needs Afrezza ASAP!

Division of Drug Information
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

Email: (Send Email: To Whom It May Concern or FDA)

To whom it may concern,

The FDA approval process for AFREZZA has been a long, painful, excruciating delay for long suffering diabetic patients who need this life changing, and indeed life saving therapy.

Currently available prandial meal time insulin drugs on the market are insufficient to meet patients needs in many ways. The first and most obvious benefit of AFREZZA is that it is inhaled. This allows patients to avoid the inconvenience, social stigma and embarrassment, pain and side effects (injection site inflammation, bruising, scar tissue, and infections), of well over 1,000 unnecessary injections per year. Not to mention no longer having to tote around needles, syringes, vials, alcohol swabs, finding refrigeration while traveling, finding private and clean places to inject everywhere you go, etc… You don’t have to have full blown needle phobia to have a healthy appreciation for the benefits that would come from no longer being a human pin cushion for the rest of your life! Is there a single person in the US who would prefer an extra thousand + injections per year?! I’ve never met one.

But the fact that AFREZZA is conveniently inhaled is not even close to being it’s most important advantage. There are so many unique and novel benefits that AFREZZA alone brings to the table that it’s hard to list them all, but allow me to make an attempt:

1. AFREZZA’s Ultra Rapid Action is nearly an exact mirror to the endogenous post prandial insulin spike in a healthy non diabetic body, and as such it enters the body quickly and is active during the correct time frame to handle the meal time spike in blood sugar

2. As a physiologic meal time prandial insulin it is even more critical that it does its job and then rapidly exits the body without leaving behind a long insulin “tail” that leads to dangerous drops in blood sugar/hypoglycemic events, and insulin stacking problems. The currently available prandial insulin products, even the “rapid acting” insulins such as Humalog and Novolog are way too slow and linger for way too long after meal time digestion is over. This leads to these currently available insulins transitioning from prandial insulins to becoming “more basal” insulin. This effect does lower HbA1c levels making them appear more efficacious to the ignorant/uninitiated, but that IS NOT A GOOD THING (though the closed minded FDA staffers would have us believe otherwise)! HbA1c as a long term average is a very poor and incomplete statistical measure for quantifying how you are managing your diabetes. The trials for AFREZZA heavily relied on HbA1c endpoints whilst discounting more important measures such as fasting blood glucose levels, time spent in target range, leveling out blood sugar levels with higher lows and lower highs, reduced weight gain, less hypoglycemic events, etc…

3. Defensive snacking is largely eliminated with AFREZZA leading to weight loss, there is no longer a need to “feed the insulin” or face the risk of immediate coma or death.

4. Complex mealtime titration is not necessary due to the PK/PD of AFREZZA. This is huge for patient convenience and compliance

5. Constant finger pricks for blood glucose monitor testing is greatly reduced due to the PK/PD of AFREZZA. THIS IS A HUGE BENEFIT that the FDA has completely ignored. This is yet another way that the real world use of AFREZZA helps the patient move away from being a human pin cushion!

6. AFREZZA has absolutely zero side effects for the vast majority of patients, and very very minor side effects for a tiny minority of patients, such as a minor cough that quickly goes away as you adjust to inhaling the medicine. This drug is very safe, and very effective. In fact AFREZZA will be one of the safest and most effective drugs the FDA will ever approve.

7. AFREZZA will be (by orders of magnitude) the best insulin product on the market for making between meal adjustments for all diabetics across the spectrum of the disease. Currently available prandial insulins are far too slow. AFREZZA allows us to live in real time for the first time. Even patients who choose not to use AFREZZA as their everyday bolus, will NEED to have this product at their disposal for just this reason.

8. AFREZZA is the only prandial insulin with the Ultra Rapid Action needed to close the loop for the artificial pancreas. It’s the missing piece that allows this project to move forward.

9. The unique and novel PK/PD of AFREZZA allows the patient to know their blood sugar levels are safe when they go to bed and not fear dying in their sleep as occurs with currently available products.

10. Patients on AFREZZA have far less blood sugar extreme highs and lows which lead to a myriad of health problems: blindness, organ failure, amputation, coma, death.

11. AFREZZA will be the first and only Ultra Rapid Acting insulin.

12. AFREZZA is easy for anyone to use, even the elderly and young children. The device is a marvel of modern design, small, efficient, and effective. Simple to use, inexpensive and disposable, few moving parts, you don’t even have to break it down and clean it! This is exactly the type of revolutionary product that the FDA needs to make available to the public

13. Approval of AFREZZA opens up the Technosphere drug/device platform for pharma development for many other innovative products to come such as pain relief medicines and vaccines. This is the type of innovation that the United States needs to remain the world leader for, lest we by surpassed by companies in other countries, and we are forced to watch the United States take a back seat.

14. AFREZZA breaks down every barrier that physicians and patients face in initiating insulin therapy: 1. Needles, 2, Weight Gain, 3. Fear of Hypoglycemic Events, 4. Complicated Educational Process, 5. Gaining Patient Compliance

15. Research indicates that AFREZZA slows the progression of the disease. More studies are necessary for a final verdict, but wow–what a benefit!

As a side note, I was embarrassed for the FDA watching your staff in the webcast of the AFREZZA Advisory Committee meeting. The FDA staff are obviously not diabetic as they have no clue about the disease and how it is managed in the real world. The FDA staff lack even a basic fundamental grasp of the Ultra Rapid Acting PK/PD profile of AFREZZA and the many new novel and unique benefits this drug brings to patients. I hope the expert panelists and public speakers (with their 3 min. time limit) were able to educate the clueless FDA staffers who seem incapable of thinking outside of their rigid box (A1c, A1c, A1c). During the public session how many diabetic patients and doctors gave impassioned testimony about the hypoglycemic benefits AFREZZA brings to the table, where the FDA staff tried to deny this effect?! I hope they were just playing “Devil’s advocate” and didn’t actually believe the filth they were spewing, or God help us, we’re in trouble regarding FDA approval for AFREZZA! As has been said the deeply flawed FDA process is forcing MannKind to hammer a square peg into a round hole. But against all odds, MannKind has indeed been able to meet the FDA endpoints that were stacked against them. They did indeed hammer that square peg through the round hole and achieve the nearly impossible! The FDA says that patients don’t prefer AFREZZA based on a few people who quit the trials. How about you ask the majority that completed the trials and can’t bear the thought of not having this important therapy at their disposal?! The FDA is ridiculous!

We’ve been waiting literally years for FDA approval for AFREZZA. Enough is enough! At this point it’s very difficult to stomach yet another delay from your side. We shouldn’t have to wait one more day for approval, so why do you ask us to wait for 3 more months? What do you not know about the AFREZZA application that you haven’t had an opportunity to discover over the past 3 years this drug has been tied up in the FDA regulatory process?! How much more can you ask from MannKind after they’ve spent over 10 years and almost $2 BILLION following your rules getting to this late stage in the game, only to face yet another 3 month delay? How much more patience can you ask from long suffering diabetes patients that NEED this life improving and indeed life saving product?