We’re monitoring today’s meeting of the FDA advisory committee on Palforzia, a novel but controversial treatment that uses calibrated quantities of ingested peanut powder to protect people against severe peanut allergy. Check back here often for updates throughout the day.
Let’s get this FDA panel started
8 a.m.: The FDA advisory panel will be a pivotal moment for Aimmune Therapeutics, the biopharma company that developed the new treatment. If approved, Palforzia (formerly AR101) will be the first protective therapy for peanut allergy and the start of what Aimmune hopes will be a family of products with blockbuster commercial potential — all designed to benefit the millions of people who suffer with life-threatening food allergies.
But the benefit demonstrated by Palforzia comes with some significant tolerability and safety concerns, which is where the crux of today’s advisory panel debate is expected to focus.
Drug czar it’s not ‘all good’. It would be all good if no one had any food allergies and no one died of anaphylactic shock every week but that’s not true. Don’t be naïve. Maybe you’re some sort of do it yourself doctor who plans to go around helping everyone who has a peanut allergy figure out how to administer peanut flour but it doesn’t work that way. My son started off on a dose of about a 300th of a peanut and gradually worked up to the point where he can eat a peanut M&M every other day, and it took a year and doctor guidance and a lot of work. My son would often feel lethargic for an hour after having his peanut dose so we had to plan around his very busy schedule. Do not trivialize this life-changing process for anyone who’s lucky enough to be involved with it. I’m not sure what your agenda is but you should maybe think about it before you start trying to suggest that this therapy has less value than it does. Not to mention the incredible implications for all the other very serious allergies that people have to other nuts, shellfish, milk, soy, wheat, eggs, etc.
Can this treatment be used by someone in their late twenties? I am very impressed by this potential peace of mind for parents.
While l I appreciate Dr. Kelso‘s remarks and perspective that peanut allergy deaths are rare in the world, they are very real to those of us who have kids who are affected. I would doubt that Mr. Kelso has raised a peanut allergic child because if he did he might realize that anything that reduces the chances of your kid having a fatal anaphylactic reaction is worth doing. My 16-year-old son had his first dose of epinephrine at age 2 1/2 after ingesting some peanut on Halloween and thank God I had epinephrine for my daughter who is 16 months older than him and had already been diagnosed with peanut allergy. That EpiPen probably saved his life. My daughter was lucky enough to be part of the approximately 15 to 20% of kids that outgrow their peanut allergy but my son was not, so for the next 12 years of his life my wife and I were constantly having to make sure we had epinephrine as well as educating schools, friends, peers, and everybody who came into contact with our son about the dangers of accidental peanut exposure. From what I’ve read regarding fatal anaphylactic reactions to peanut, approximately one person a week under the age of 18 dies from an accidental exposure to peanuts. Dr. Kelso mentions this rate is rare, but for those families affected by the allergy that number is way too high, and totally unacceptable. My son was lucky enough to participate in the AR 101 study and now eats 3 to 4 peanut M&Ms a week as a 16-year-old. It has been one of the most dramatically significant and positive changes in his life, allowing him to have a job at an ice cream shop and allowing him to travel without his parents for soccer tournaments and do many other things that in the past were not possible due to his peanut allergy. It’s been completely life-changing for him, and for us. Please keep these facts in mind when you comment about whether these kinds of therapies should be approved or not.
Totally agree. I didn’t see a transcript of his statements, but Kelso seems to be totally discounting quality of life and the mental health of patients and their caregivers. My daughter has yet to go through OIT (too young) but we are eager to to get on this drug asap. And by the way, having an anaphylactic reaction at a doctor’s office or in your home when you are ready and prepared is a far cry from having one at a random time when you arent expecting it (and when primary caregivers may not even be around). I’d gladly take a TINY increase in the chance for the former if it eliminates the chance of the latter.
It’s all good. Just keep in mind that AR101 is nothing more than defatted peanut flour (as described in their trial, and the defatting is unlikely to have any therapeutic role). That is, you can buy a bag of it for a few bucks in a grocery store, and use a precision scale to dose it. And save thousands of dollar in out of pocket or premium costs
ADMP epinephrine drug going to benefit if this gets approval requiring you have epinephrine to use the script.
don’t be mad you didnt buy it at $12
It is beyond ridiculous, they are going to approve simple peanut flour as a therapeutic. It deserves the title of greatest scam in the history of medicine
Please don’t confuse a majority or all of the speakers with “overwhelming public support. ” Those who will profit from this approval will make sure their side is well represented- -beyond encouragement some public speakers will have been reimbursed for their travel, perhaps their time. They have been coached on how if approval is not gained they or their children will be out if the trial. The stakes are high for the study participants. Only the FDA is speaking at these meetings on behalf of those put at unnecessary risk or pointing out weak data, but they are outshouted by emotion.
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