Life with food allergies can be stressful and scary, especially if you are the parent or caregiver of a child with severe allergies. That’s why families and medical providers in the food allergy space are rejoicing after the US Food and Drug Administration (FDA) approved Xolair, the first drug to treat severe food allergies in children and adults. .
“This is huge for families with food allergies because, until now, there have been few FDA-approved treatments to reduce the severity of food allergies, which can be life-threatening,” said Dr. Purvi Parikh, an adult and pediatric allergist and immunologist practices in New York City.
Here’s what you need to know about the new drug, including how it works, where to get it and what it means for the future of medical care for adults and children with severe food allergies.
What is Xolair, and which food allergies does it treat?
Xolair, the brand name of the drug omalizumab, is an injection given every two to four weeks to help reduce the potential for a serious allergic reaction in the event of an accidental exposure. The drug is approved for use in adults and children younger than 1 year who are allergic to a variety of foods including:
- Milk
- Eggs
- nuts
- cashew
- Walnuts
- Hazelnuts
Xolair was previously approved by the FDA to treat other conditions, including some types of asthma, chronic hives and chronic inflammatory sinus disease. Its approval as a food allergy treatment is based on the results of the OUTMATCH clinical trial, sponsored by the National Institutes of Health. During the trial, 68% of peanut-allergic patients aged 1-55 who took Xolair for at least 16 weeks were able to consume small amounts of peanuts without severe allergy symptoms. Similar results were seen in:
- 67% of participants allergic to eggs
- 66% of participants allergic to milk
- 42% of participants allergic to cashews
Xolair works by binding to immunoglobulin E (IgE), the type of antibody that triggers allergic reactions, and preventing those antibodies from attaching to receptors in the body. According to Xolair’s manufacturer Genentech, there are 160 different foods that can cause IgE-related food allergies, and about 3.4 million children and 13.6 million adults in the US have been diagnosed. have food allergies. A doctor or allergist can help you determine if specific food allergies can be treated with medication.
Does Xolair cure food allergies?
Xolair does not cure food allergies, and it should not be used as an emergency treatment during an allergic reaction, the FDA warns. This is meant to be a protective measure to reduce the chance of a reaction following accidental exposure to certain foods.
“You still need to bring an EpiPen [Epinephrine shot] and avoid foods you’re allergic to.”
—Dr. Purvi Parikh, allergist and immunologist
“It’s an extra layer of protection when you come into contact with a food allergen, so you don’t have as severe an allergic reaction,” explains Parikh. “You still need to bring an EpiPen [Epinephrine shot] and avoid foods you’re allergic to.”
What are the side-effects of Xolair?
The most common side effects of Xolair include fever and injection site reactions, such as pain and swelling, Dr. Ahmar Iqbal, an executive medical director at Genentech who co-authored the OUTMATCH study. Plus, he added, “there was no patient who failed [the trial] because of bad events.”
Some less common potential side effects of Xolair may include:
- Joint pain.
- Rash.
- Headache.
- Dry throat.
- Congestion.
- Body aches or pains.
Xolair also has a warning that the drug itself can trigger anaphylaxis; however, this reaction is very rare. A doctor can help determine your individual risk. “Xolair has been on the market for more than 20 years and has a very safe side effect profile,” Parikh added. “As with any injectable med, there is a risk of a serious allergic reaction, but most patients have no issues and tolerate it very well.”
When will Xolair be available?
Xolair is now available, and can be prescribed by any doctor, pediatrician or allergist. Additionally, patients seeking the drug should check with their insurance company to see if it is covered. The cost of the drug without insurance can range from $2,900 a month for children and $5,000 a month for adults, according to the Associated Press.
The bottom line on Xolair
Xolair is not a cure for food allergies, but its approval represents a big step forward for allergy patients of all ages.
“No matter how diligent people with food allergies are to avoid the foods they are allergic to, the possibility for an accidental exposure is always there,” said Dr. Larry Tsai, the global leader of respiratory, allergy and infectious disease product development. at Genentech and father to a child with multiple food allergies. “For the first time, people with one or more food allergies have a treatment option with Xolair that can help reduce allergic reactions that can occur with an accidental exposure.”
Xolair can help prevent severe reactions to some of the most common food allergens, such as milk, eggs and certain nuts. Having this treatment option can save lives. Hopefully Xolair’s approval will lead to more research and treatment options for those living with food allergies.
