TALKING POINTS

• The real story behind getting Xolair approved for food allergy — including the resistance he encountered not just from the broader medical community, but from Genentech (the drug’s own maker) and the FDA itself
• What Xolair’s approval means in practical terms: the first FDA-approved treatment for food allergy in young children and in adults, the first for any food allergy beyond peanuts, and the first for patients with multiple food allergies
• Life on Xolair for patients — not a cure, and avoidance still matters, but accidental exposures become far less dangerous, changing what’s possible day to day (school, restaurants, parties, travel)
• What Xolair actually is and how it works — a monoclonal antibody that neutralizes IgE, the antibody responsible for most food-allergic reactions and anaphylaxis
• Why a drug already approved for asthma faced years of internal resistance before anyone would pursue it for food allergy — cost, an expiring patent, no regulatory precedent, and skepticism that food allergy was “serious” enough to warrant a biologic
• The personal risk of leaving a 30-year academic career and a tenured professorship at Harvard to join Genentech, betting he could push Xolair through from inside the company
• What the book offers beyond the medical story — a rare inside look at how slow and political the drug approval process can be, even once a treatment is proven to work

QUESTIONS & ANSWERS

1. Tell us about your book, why readers should read this. What’s different about it?
I wrote this book to tell the story of the ups and downs of getting the first medication for young children and adults with food allergies approved by the FDA. Until this medication, called Xolair, was approved, these patients had no treatment, except to avoid the offending food, and treat allergic reactions that would occur with accidental exposures.

So I believe that this book will be of great interest to any patient with food allergy. These patients can learn about the circuitous journey that Xolair took to get FDA approval. But it’s also of interest to others because it provides insight into the sometimes-protracted process by which drugs get approved by the FDA.  

2. What does the availability of Xolair for food allergy mean for patients with food allergy?  
Xolair’s approval for food allergy has been a real game changer. It’s the first FDA approved treatment for food allergy in very young children and the first in adults; it’s the first approved treatment for any food beyond peanuts. It’s the first treatment for patients with multiple food allergies. Now, it is the only FDA approved treatment available to treat any food allergy. 

It’s not a cure, and while on Xolair, patients still need to avoid the offending foods. However, accidental exposures are much, much less of an issue, since Xolair protects the vast majority of treated patients from serious allergic responses including anaphylaxis, should they have an exposure. For patients, this makes going out into the community, going to school, day care, restaurants and parties where food is served much less risky. So now finally food allergy can be effectively managed. 

3.Why did you write this book? 
As a clinician-scientist for many years, I was very much aware of the lack of effective treatments for patients with food allergy. But when we found, after exploring different approaches to food allergy, that Xolair was highly effective for food allergy, surprisingly, most people, including Genentech, the maker of Xolair, were not interested in pursuing this idea. So I wrote this book to bring to light how we pushed back against this strong resistance that came not only from the medical community, but also from Genentech and the FDA. Ultimately, after years of struggle, we did get FDA approval for Xolair for food allergy and it is now available for these patients. 

4. What is Xolair? 
Xolair is a biologic, which means that it is a monoclonal antibody (mAb), created with recombinant DNA methods. Normally antibodies, which are proteins in the blood that fight infection and remove foreign invaders, are all very different and heterogenous, since they bind to many different antigens. In Xolair, all of the antibodies are identical (monoclonal), and they all only bind to and neutralize IgE, which is the antibody that causes most food allergies, including anaphylaxis. 

5. How does it work?
By neutralizing IgE, Xolair takes away the ability of the patient to recognize and respond to allergens. So treatment with Xolair prevents virtually any food from triggering an allergic response and anaphylaxis in food allergic patients.  

6. What is Xolair used for?
Before I joined Genentech, Xolair was approved for just one thing—allergic asthma in adults and adolescent patients. Since I joined Genentech in 2013, Xolair has been approved for pediatric asthma, chronic idiopathic urticaria, nasal polyps and now food allergy (since 2024). Xolair is now a very important product for Genentech, much more important than anyone expected. 

7. Why was there resistance for moving Xolair forward to treat patients with food allergy?
I think that there were several reasons. 

• First, Xolair is a biologic, an expensive product generated with recombinant DNA technology. For many people, using Xolair for food allergy was overkill. Many mAbs were being used for treating serious diseases like cancer. But food allergy was not thought to be a serious disease, which I of course disagreed. 
• Second, Xolair was an old product; the patent was expiring; and at Genentech, there were many newer, more exciting treatments for many other diseases that Genentech wanted to invest in. In addition, because there were no other FDA approved treatments for food allergy, there was no precedent. So the idea of developing a biologic for food allergy was too novel for people at Genentech (and in the pharmaceutical business) to embrace. 
• The FDA initially also had significant reservations. Since there were no previously approved treatments for food allergy, they were not sure how to deal with a biologic for food allergy.   

8. What made you leave academic medicine and a tenured professorship at Harvard Medical School to join the pharmaceutical industry? What were you thinking?
Deciding to make that move was very difficult for me. I had been in academic medicine for thirty years and enjoyed teaching, seeing patients, doing research and being part of the university community. But I knew that my patients with food allergy needed better treatments, and I knew that Xolair was incredibly effective for food allergy. Unfortunately, because Genentech was not interested in getting Xolair FDA approved for food allergy, it would never be available to patients with food allergy. 

Then, as we were showing how effective Xolair was for food allergy, an opportunity arose at Genentech. I was crazy enough to think that I might be able to do more from within Genentech to get Xolair available to patients. So I left academic medicine to join Genentech, even though I knew very little about the pharmaceutical industry. It was a very risky, perhaps zany move, but I felt that sometimes, you need to take calculated risks in order to pursue something that you deeply believe in. Luckily, my move did indeed eventually lead to FDA approval of Xolair for food allergy.