The FDA authorizes medication to alleviate the intensity of allergic responses to peanuts, dairy, and other foods.

Food allergy sufferers have a new weapon in their fight against severe symptoms.

The FDA has approved the use of injectable Xolair (omalizumab) to reduce the risk of severe reactions to specific foods.

The FDA approved Xolair for treating immunoglobulin E-mediated food allergies in adults and children aged 1 year or older on February 16.

The FDA has approved the first medication to reduce allergic reactions following accidental exposure to multiple food types, the agency announced.

The multicenter study that led to the FDA approval was conducted by Robert A. Wood, M.D.

According to Wood, director of the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins University School of Medicine in Baltimore, Maryland, treatment options for the millions of Americans with severe food allergies are limited to strict avoidance.

"Accidental exposures to food allergens often cause fear for the lives of patients and their families, even with strict avoidance measures."

Wood stated that the approval of Xolair for treating food allergies could be highly significant and potentially life-changing for those affected.

The Asthma and Allergy Foundation of America (AAFA), a nonprofit located in Maryland, was not involved in the medication research but spoke with Planet Chronicle Digital about the recent approval.

Mendez stated that the stress of dealing with food allergies can greatly affect individuals and their families, especially during events such as children's birthday parties, school lunches, and holiday dinners with friends and family.

"With the increasing occurrence of food allergies, this news provides hope for the numerous children and adults who can benefit from a novel approach to managing their allergies."

Even if taking Xolair, individuals must still avoid foods they're allergic to, as per the FDA's announcement.

The FDA has approved a new use for Xolair, which will offer a treatment option to reduce the risk of severe allergic reactions in specific patients with IgE-mediated food allergies, according to Kelly Stone, M.D., PhD, the associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA's Center for Drug Evaluation and Research.

"Although it won't eradicate food allergies or enable individuals to eat allergens without restriction, consistent application can minimize the adverse effects of unintentional exposure."

Risk reducer, not cure

Genentech's Xolair, located in California, is not authorized for immediate emergency treatment of allergic reactions and should not be considered a replacement for current emergency treatments, according to the federal agency.

Health experts informed Planet Chronicle Digital that emergency treatments for severe allergic reactions, such as doses of epinephrine and EpiPens, can prevent anaphylaxis, which can be fatal.

Over 40% of American children with food allergies have visited the emergency department, according to the Centers for Disease Control and Prevention (CDC), while nearly 6% of U.S. adults and children are affected by food allergies.

Allergic reactions resulting from food exposure are commonly seen by Dr. Fred Davis, the associate chair of emergency medicine at Northwell Health in New Hyde Park, New York.

He informed Planet Chronicle Digital that this drug could potentially decrease that risk.

Davis advised that this drug is for preventing allergies, not for treating them during an acute reaction.

"This news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."

Dr. Susan Schuval, head of the Division of Pediatric Allergy/Immunology at Stony Brook Children's Hospital, stated that the recent FDA approval of Xolair for food allergies is a significant step forward for the 33 million Americans affected by this condition.

Schuval stated that while Xolair does not cure food allergies, it can reduce the risk of severe reactions from accidental food exposures. However, patients must still practice food avoidance and carry epinephrine injectors.

The CDC advises strict avoidance of any foods that trigger food allergies since there is currently no cure for them.

In the U.S., the most common triggers of serious allergic reactions are milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts, according to the agency.

Severe food allergies, caused by a mistaken immune response, occur when the body perceives a food particle as a harmful invader.

Immunoglobulin E (IgE) is a type of antibody that plays a role in the immune response, potentially causing stomach problems, itching, hives, or anaphylaxis, as stated by several health experts.

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

According to Davis, the injection blocks IgE and reduces the likelihood of an allergic reaction, but it must be taken consistently to be effective.

Research behind the approval

The effectiveness and safety of Xolair were evaluated in 168 participants, including babies and adults, and the FDA made its approval decision based on this study.

At least two other foods, aside from peanuts, caused allergic reactions in all participants, which were milk, wheat, egg, walnut, hazelnut, or walnut.

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

Those who received Xolair were able to tolerate 2½ peanuts without a moderate or severe allergic reaction, compared to 6% who took the placebo.

Among those who received Xolair injections, 67% of people with egg allergies, 66% of people with milk allergies, and 42% of people with cashew allergies were able to consume a single dose of cashew, milk, or egg protein without experiencing moderate to severe allergic symptoms.

It is advised that an individual should only begin the medication in a healthcare facility capable of managing anaphylaxis, as recommended by the agency.

Experts advised patients to consult with their healthcare provider before deciding if Xolair is the appropriate treatment for them.

Planet Chronicle Digital reached out to the FDA for additional comment.

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