“The approval is based on data from the NIH-sponsored Phase III efficacy trial (OutMATCH), which showed that compared to placebo, a significantly higher proportion of patients with food allergies as young as one year of age, who (…) were treated tolerated small amounts of peanuts, milk, eggs and cashew nuts without an allergic reaction,” wrote the Swiss pharmaceutical company Roche in a release on Friday evening.
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 20 years. About half of these people have already suffered a severe allergic attack due to contact with the allergen, to which their immune system overreacts. In the USA, around 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 seizures.
Apart from avoiding the allergen, there have been hardly any medical treatment options. The humanized monoclonal antibody Omalizumab, which has been allowed to be used in the EU since 2005 in the treatment of 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 has an effect
The effectiveness study included subjects who could not tolerate a dose lower than one hundred milligrams (one tenth of a gram) of peanut protein (about a third of a peanut). The test subjects also had to have allergic reactions to milk (300 milligrams), eggs and cashew nuts. Every two or four weeks they received either the monoclonal antibody or a placebo injected under the skin.
The drug was effective: After 16 to 20 weeks, 68 percent of those treated 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 did not have an 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 the patients who received a placebo.
Omalizumab works by blocking immunoglobulin E antibodies in the medium term after the injection. This prevents the release of those immune messenger substances from certain white blood cells (mast cells) that trigger allergic reactions. The most important thing here is histamine.
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