FDA Approves First Drug For Treating Multiple Severe Food Allergies

The US Food and Drug Administration (FDA) has granted approval for the first drug of its kind for treating multiple severe food allergies at the same time.

Drug For Treating Multiple Severe Food Allergies

People who suffer from severe food allergies may now have a new way to handle their dangerous reactions after being accidentally exposed to these food allergens.

The FDA has just approved a drug known as Xolair, with the generic name of omalizumab, for treating multiple severe food allergies. This injectable treatment is considered a monoclonal antibody, which means it has lab-made proteins that can latch onto a specific target within the body. Once it is inside a person, the drug takes hold of IgE (immunoglobulin E), which is a kind of body-made antibody that primarily handles allergic reactions.

IgE drives several food allergies, such as allergies to eggs, milk, peanuts, soy, fish, tree nuts, wheat, and shellfish.

In the past, Xolair was approved for treating other conditions, such as allergic asthma. However, this recent approval implies that it can be used to help combat allergic reactions due to several food triggers. Dr. Kelly Stone, the associate director of the Division of Pulmonology, Allergy, and Critical Care in the Center for Drug Evaluation and Research of the FDA, shares that Xolair's newly approved use will offer a treatment option to decrease harmful allergic reaction risk among patients who deal with food allergies mediated by IgE.

Dr. Stone explains that the drug will not eliminate the allergies or enable the patients to freely consume these allergens. Rather, its repeated use will help reduce the impacts of accidental exposure.

The drug will also not become a replacement for epinephrine injections (EpiPen devices), which are used for reversing a body-wide and life-threatening allergic reaction known as anaphylaxis. These EpiPen injections help keep the airways of a person open and blood pressure stable when they get exposed to such allergens and have dangerous reactions.

In contrast, Xolair is to be injected every two to four weeks. This is to be done preventively in order to help people develop tolerance towards such allergens and consequently reduce allergic reaction severity if accidental exposure occurs.

According to Genentech, the distributor of the drug, the recommended timing and dosage of the injections may vary depending on a person's IgE level in the body and body weight. These injections may be administered at home or by a healthcare provider. This would depend on the method that the clinician deems appropriate.

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Clinical Testing

The drug underwent a clinical trial covering almost 170 adults and children who were at least one year old. All participants had allergies to peanuts and at least two more foods. Such food allergies were confirmed through different tests, including an IgE test and skin-prick tests. Throughout the course of the trial, participants received the drug or a placebo for four to five months.

Researchers observed that 68% of those who took Xolair could consume a dosage of peanut protein without exhibiting moderate-to-severe allergy symptoms, such as vomiting or whole-body hives. This figure is compared to just 6% of the group receiving the placebo. The researchers were also able to observe similar improvement rates when it came to allergic reactions to milk, cashews, and eggs.

Moreover, 17% of people who took Xolair did not see any peanut tolerance change as time passed. Because of this, the FDA cautioned that strict allergen avoidance is still important.

Among the side effects observed, the most common ones were fever as well as injection site reactions. The label of the drug warns of possible joint pain, fever, rashes, and parasitic worm infections.

On top of this, the FDA stressed that the initial administration of Xolair should be done in a healthcare setting. This is because there have been cases where patients experienced anaphylaxis shortly after the drug was administered to them.