FDA approves the first drug for treating severe food allergies
What's the story
The U.S. Food and Drug Administration (FDA) has given the green light to Xolair, a medication designed to reduce severe allergic reactions caused by accidental exposure to certain foods like dairy products and nuts.
It is the first FDA-approved drug that can help protect individuals against multiple food allergies.
The drug was developed and co-promoted in the US by Novartis Pharmaceuticals and Genentech.
About the drug
How Xolair works
Xolair is not meant to be used during an allergic reaction, instead it should be taken every few weeks to lower the risk of reactions over time.
The FDA recommends that people taking Xolair continue to avoid foods they are allergic to.
It is intended for use in individuals with immunoglobulin E (IgE)-mediated food allergies who are one year of age or older and unintentionally come into contact with one or more potentially allergic foods.
Study
Xolair's effectiveness
The efficacy of the drug was studied in a research involving 168 adults and children who were allergic to peanuts and a minimum of two other foods, including wheat, milk, and nuts such as cashews, hazelnuts, or walnuts.
The study showed that 68% of those who took Xolair for four to five months could consume about 2.5 peanuts without experiencing moderate or severe allergic symptoms like body hives, persistent coughing or vomiting, according to the FDA.
Findings
Study findings
The research found that Xolair was effective after four to five months in 67% of people allergic to eggs, 66% of people allergic to milk, and 42% of people allergic to cashews.
The cost of the medication ranges from $2,900 (over Rs. 2.4 lakh) a month for children and $5,000 (over Rs. 4.1 lakh) a month for adults, though insurance may help lower the cost.
Side effects
What you need to know about the drug
Kelly Stone from the FDA's Center for Drug Evaluation and Research stated that while the drug will not eliminate food allergies completely or allow allergic people to consume food allergens freely, its repeated usage will aid in reducing the health impact if accidental exposure occurs.
Some common side effects include fever and a reaction at the injection site.
The medication itself can also cause anaphylaxis, so Genentech advises that a healthcare provider monitors a person starting to use Xolair.