They have found out that the drug can be used for a different purpose.
Individuals facing the constant threat of accidental exposure to allergenic foods may find a new line of defense with the expanded use of the asthma medication Xolair, announced by the U.S. Food and Drug Administration (FDA) on Friday.
Xolair, an injectable drug, is not intended to replace emergency treatments like EpiPens for anaphylaxis; instead, it is meant for repeated use to reduce the risk of allergic reactions, as emphasized by the FDA. Manufactured by Genentech, Xolair was originally approved in 2003 for the treatment of moderate to severe allergic asthma. Over time, it has also gained approval for managing a skin rash called urticaria and chronic rhinosinusitis with nasal polyps in specific patient groups.
As the first medication approved to mitigate allergic reactions to various types of foods, Xolair functions as a monoclonal antibody that blocks the action of immunoglobulin E (IgE), the antibody implicated in triggering allergic responses.
Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, expressed optimism about the new indication for Xolair, highlighting its potential to reduce the health risks associated with accidental food allergen exposure.
Although Xolair does not eliminate food allergies or grant individuals the freedom to consume allergenic foods without consequence, its regular use can mitigate the impact of accidental exposure.
Expanding Xolair’s usage to include individuals allergic to various foods represents a significant market expansion for the drug, particularly considering the prevalence of food allergies in the United States.
While Palforzia addresses anaphylaxis prevention in peanut allergy patients, Xolair now stands as the sole treatment option covering multiple food allergies.
The safety and efficacy of Xolair were demonstrated in a trial involving 168 participants allergic to peanut and at least two other foods. The results showed that a majority of those receiving Xolair were able to tolerate peanut protein without severe allergic symptoms compared to those receiving a placebo.
However, it’s essential to note that Xolair did not diminish overall peanut allergy; therefore, strict allergen avoidance remains necessary alongside treatment.
Given the potential for anaphylaxis in some patients, the FDA includes a boxed warning with Xolair, cautioning against its use in individuals with a history of severe hypersensitivity to the drug or its components.
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