A monoclonal antibody previously used to treat severe allergic asthma has now become the first drug for food allergies in the United States. The US Food and Drug Administration (FDA) announced the approval.
“The approval is based on data from the NIH-sponsored Phase III efficacy study (OutMATCH), which showed that compared with placebo, a significantly greater proportion of patients with food allergies from age one year onwards who were (…) treated with small amounts of peanuts, milk, eggs and cashew nuts without allergic reaction,” the Swiss pharmaceutical company Roche wrote in a broadcast on Friday evening.
No treatment options yet
In the United States alone, food allergies affect 3.4 million children and 13.6 million adults. The number of these diagnoses has risen steadily over the past twenty years. About half of these people have already suffered a severe allergic attack as a result of contact with the allergen, to which their immune system overreacts.
In the US, approximately 30,000 patients are treated in emergency rooms every year with the most serious complication: anaphylactic shock. In the case of peanut allergies, the smallest amounts are often enough to trigger attacks.
Other than avoiding the allergen, there have been few medical treatment options. The humanized monoclonal antibody Omalizumab, which has been authorized for use in the EU since 2005 to treat allergic asthma that is otherwise not adequately controlled, was ideal for testing. In 2018, the FDA granted omalizumab “breakthrough therapy” status in the treatment of food allergies or for the prevention of severe allergic reactions in people with food allergies. This should speed up approval.
The medication had an effect
The effectiveness study involved subjects who could not tolerate a dose of less than one hundred milligrams (one-tenth of a gram) of peanut protein (about one-third of a peanut). The test subjects also had to have an allergic reaction to milk (300 milligrams), eggs and cashew nuts. Every two to four weeks they were injected with the monoclonal antibody or a placebo under the skin.
The drug was effective: After 16 to 20 weeks, 68 percent of treated individuals tolerated at least 600 milligrams of peanut protein without an allergic reaction; in the placebo group this was only the case for five percent. 66 percent had no allergic reaction to 1,000 milligrams of milk protein, two-thirds also tolerated egg protein (a quarter of an egg) and cashew allergies also improved compared to patients who received a placebo.
Omalizumab works by blocking immunoglobulin E antibodies in the medium term after injection. This prevents the release of those immune messenger substances from certain white blood cells (mast cells) that cause allergic reactions. The most important thing here is histamine.
Source: Krone
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