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FDA's Approval of Xolair: A Turning Point in Food Allergy management

The FDA approval

The FDA gave approval to the first drug to decrease severe allergic reactions caused by inadvertent exposure to specific foods.


According to the FDA, more than one in every twenty people in the United States are allergic to at least one food, which can cause extreme and potentially fatal allergic reactions.

Xolair (omalizumab):

Xolair was initially approved to treat moderate to severe chronic allergic asthma in some patients. It is a is a medication (a monoclonal antibody) that binds to immunoglobulin E (IgE), the type of antibody that causes allergic reactions, and prevents IgE from connecting to receptors.


Omalizumab is used in the treatment of moderate to severe asthma caused by allergens in adults and children over the age of six. It helps treat asthma symptoms when inhaled steroids do not work and treats adult nasal polyps that do not respond to nasal steroids.


It is also used in the treatment of chronic hives (idiopathic urticaria) in adults and children over the age of 12 after antihistamines have failed.

The Clinical Trials

A placebo-controlled, multicentre trial showed the safety and efficacy of Xolair in decreasing allergic responses in patients with food allergies. The study involved 168 pediatric and adult individuals who were allergic to peanuts and dairy foods such as eggs. Milk along with cashew, walnut, hazelnut etc. For 16 to 20 weeks, participants were randomly given Xolair or a placebo.

For Xolair, 68% could eat a single dose of peanut protein without experiencing moderate to severe allergic symptoms. 17% of participants taking Xolair exhibited no significant difference. Hence even after using Xolair, it is highly important to avoid allergens.

What are food allergies?

Food allergies typically are the reaction of the body’s immune system that may develop when the body incorrectly recognizes a certain food or dietary component as dangerous. This causes the immune system to create antibodies, such as immunoglobulin E (IgE), which result in the production of substances like histamine, causing allergic symptoms.

A few common food allergens include:

  • Peanuts
  • Milk
  • Eggs
  • Soy
  • Fish
  • Walnuts
  • Almonds
  • Shellfish

However, these are a few most common allergens any food can potentially cause allergies which can individual individual-specific.

Symptoms of food allergies include:

  • Itchy skin
  • Vomiting and nausea
  • Pain in the abdomen
  • face, lips and eyes swelling
  • Uncontrollable sneezing, coughing and hoarse voice
  • Dizziness
  • Rashes
  • Diarrhea

Some severe cases involve anaphylaxis involving symptoms such as breathlessness, sweating, throat swelling, and low blood pressure. It is important to seek immediate medical help in such cases. 

Source: Inputs from various media Sources

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Sanika Pande

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