FDA approves allergy drug to lessen severity of reactions to peanuts, dairy, other foods

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People with food allergies You now have a new weapon to fight serious symptoms.

The U.S. Food and Drug Administration (FDA) has given the green light for the use of the injectable drug Xolair (omalizumab) to reduce the risk of life-threatening reactions to certain foods.

Xolair was approved for “immunoglobulin E-mediated food allergies in certain adults.” Children over 1 year old” the FDA announced on February 16th.

This is the first drug approved by the FDA to reduce allergic reactions after accidental exposure to several types of foods, the agency said.

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Robert A. Wood, MD, was the principal investigator on the multicenter study that led to FDA approval.

“For the millions of Americans with severe food allergies, treatment options other than strict avoidance are extremely limited,” said Wood, chair of the division of pediatric allergy, immunology, and rheumatology at the Johns Hopkins University School of Medicine in Baltimore, Maryland. It’s limited,” he said. Fox News Digital.

The FDA has cleared the injectable Xolair (omalizumab) for use to reduce the risk of life-threatening reactions to certain foods. (St. Petersburg)

“These patients and their families often suffer from the fear of accidental exposure to food allergens, and even when strictly avoided, accidental exposure is common.”

“The approval of Xolair for the treatment of food allergies is extremely meaningful and potentially even life-changing for people with food allergies,” Wood added.

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Kenneth Mendes, President and CEO asthma and allergies The Maryland-based nonprofit American Foundation for Drugs (AAFA), which was not involved in the drug research, spoke to Fox News Digital about the recent approval.

“The stress of living with food allergies can take a toll on people and their families, especially when participating in events such as children’s birthday parties, school lunches, and holiday dinners with friends and family. Yes,” Mendez said.

“Given the increasing prevalence of food allergies, this news gives hope to the many children and adults who could benefit from new ways to manage food allergies.”

boy peanut

Milk, eggs, fish, shellfish, wheat, soy, peanuts, and tree nuts are responsible for the most serious allergic reactions in the United States. (St. Petersburg)

The FDA said in a statement that even if you are taking Xolair, you should avoid foods to which you are allergic.

“This newly approved use of Xolair provides a treatment option that reduces the risk of adverse allergic reactions in certain patients with IgE-mediated food allergies.” said Kelly Stone, M.D., associate director of the emergency department. at the FDA’s Center for Drug Evaluation and Research, the FDA said in a news release.

“Although it does not eliminate food allergies or give patients free access to food allergens, repeated use can help reduce food allergies. Health effects In the event of accidental exposure. ”

Risk reducer, not cure

Xolair, made by Genentech in California, is not approved for immediate emergency treatment of allergic reactions. It also does not replace current emergency care, the federal agency said.

Health experts told Fox News Digital that these emergency treatments include administering epinephrine and EpiPens to prevent anaphylaxis, a severe and potentially fatal allergic reaction.

food allergen test

The FDA said in a statement that even if you are taking Xolair, you should avoid foods you are allergic to. (St. Petersburg)

According to the Centers for Disease Control and Prevention (CDC), nearly 6% of adults and children in the United States suffer from food allergies, and more than 40% of children with food allergies in the United States are treated in the hospital. emergency department.

Dr. Fred Davis, associate director of emergency medicine at Northwell Health in New Hyde Park, New York, said many allergic reactions are seen due to food exposure.

“This drug may be able to lower that risk,” he told FOX News Digital.

“Remember, this is a prophylactic drug, not a drug to be used after exposure when an acute allergic reaction occurs,” Davis cautioned.

“This news brings hope to the many children and adults who could benefit from new ways to manage food allergies.”

“The recent FDA approval of Xolair for food allergies marks another important step for the 33 million Americans living with this condition,” said Stony Brook Children’s Hospital, Long Island, New Jersey. said Dr. Susan Schuval, Chief of the Department of Allergy and Immunology. York told Fox News Digital.

“Although Xolair is not a treatment for food allergies, its use may reduce the risk of severe reactions from accidental food exposure. Patients still need to be trained. avoidance of food I also carry an epinephrine syringe,” Cheval said.


Emergency treatment includes administering epinephrine and an EpiPen to prevent anaphylaxis, a severe allergic reaction that can lead to death. (St. Petersburg)

There is currently no cure for food allergies, so the CDC recommends strictly avoiding the offending food.

According to the agency, milk, eggs, fish, shellfish, wheat, soybeans, peanuts and tree nuts cause the most severe allergic reactions in the United States.

The most severe IgE-mediated food allergies occur when the body’s immune system mistakenly identifies food particles as harmful invaders.

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A type of antibody called immunoglobulin E (IgE) contributes to the immune response that causes stomach problems, itching, hives, and anaphylaxis, according to several health experts.

Xolair helps dampen this immune response by targeting specific receptors in the body.

“This is a shot that blocks IgE and reduces the risk of allergic reactions, but it must be taken regularly to be effective,” Davis told FOX News Digital.

The research behind the approval

The FDA’s approval decision was based on a study that investigated the efficacy and safety of Xolair in 168 participants ranging from infants to adults.

All participants were allergic to peanuts and at least two other foods, including milk, wheat, eggs, walnuts, hazelnuts, and walnuts.

breathing problems in women

A type of antibody called immunoglobulin E (IgE) contributes to the body’s immune responses, including stomach problems, itching, hives, and anaphylaxis. (St. Petersburg)

Participants received either Xolair or a placebo for 16 to 20 weeks.

68% of people who received Xolair were able to ingest the equivalent of two and a half peanuts without experiencing a moderate or severe allergic reaction, compared to 6% of those who took a placebo. It wasn’t.

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Additionally, among participants who received the Xolair injection, 67% of those with an egg allergy, 66% of those with a milk allergy, and 42% of those with a cashew nut allergy were more likely to consume a single serving (1,000 milligrams or more) of cashews and milk. ) could be ingested. Egg protein without moderate to severe allergic symptoms.

The agency recommended that medication should only be started in medical settings that are equipped to manage anaphylaxis.


Experts say patients should talk to their health care provider about whether Xolair is the right choice for them.

Fox News Digital has reached out to the FDA for additional comment.

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