Health
FDA approves allergy drug to lessen severity of reactions to peanuts, dairy, other foods
Food allergy sufferers have a new weapon in their fight against severe symptoms.
The U.S. Food and Drug Administration (FDA) has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods.
Xolair was approved for “immunoglobulin E-mediated food allergy in certain adults and children 1 year or older,” the FDA announced on Feb. 16.
This is the first medication the FDA has approved to reduce allergic reactions after accidental exposure to several types of food, the agency stated.
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Robert A. Wood, M.D., was the principal investigator of the multicenter study that led to the FDA approval.
“Treatment options, aside from strict avoidance, have been very limited for the millions of Americans with severe food allergies,” Wood, director of the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins University School of Medicine in Baltimore, Maryland, told Fox News Digital.
The FDA has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods. (iStock)
“The lives of these patients and their families are often consumed by fear of accidental exposure to food allergens — and even with strict avoidance, accidental exposures are common.”
“The approval of Xolair for the treatment of food allergy will be very meaningful, and potentially even life-changing, for people with food allergies,” Wood added.
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Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA), a nonprofit headquartered in Maryland, was not involved in the medication research but spoke with Fox News Digital about the recent approval.
“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches and holiday dinners with friends and family,” Mendez said.
“Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”
Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S. (iStock)
Individuals must still avoid foods they’re allergic to, even if they take Xolair, the FDA noted in the announcement.
“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, M.D., PhD, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.
“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”
Risk reducer, not cure
Xolair, made by Genentech in California, is not approved for the immediate emergency treatment of allergic reactions. It is also not a substitute for current emergency treatments, the federal agency stated.
Such emergency treatments include doses of epinephrine and EpiPens to prevent anaphylaxis, which is a severe allergic reaction that can potentially be fatal, health experts told Fox News Digital.
Individuals must still avoid foods they are allergic to, even if they take Xolair, the FDA noted in the announcement. (iStock)
Nearly 6% of U.S. adults and children suffer from food allergies, according to the Centers for Disease Control and Prevention (CDC) — and more than 40% of children with food allergies in the U.S. have been treated in the emergency department.
Dr. Fred Davis, associate chair of emergency medicine at Northwell Health in New Hyde Park, New York, said he sees a number of allergic reactions from exposure to food.
“This drug may be able to lower that risk,” he told Fox News Digital.
“Remember that this is a preventative drug, not a medication to be used after exposure when one is having an acute allergic reaction,” Davis cautioned.
“This news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”
“The recent FDA approval of Xolair for food allergies marks another important step forward for the 33 million Americans living with this condition,” Dr. Susan Schuval, chief of the Division of Pediatric Allergy/Immunology at Stony Brook Children’s Hospital on Long Island, New York, told Fox News Digital.
“Although Xolair is not a cure for food allergies, its use may lessen the risk of severe reactions from accidental food exposures. Patients will still need to practice food avoidance and carry epinephrine injectors,” Schuval said.
Emergency treatments include doses of epinephrine and EpiPens to prevent anaphylaxis, which is a severe allergic reaction that can potentially be fatal. (iStock)
As there is currently no cure for food allergies, the CDC recommends strict avoidance of any foods that cause them.
Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S., per the agency.
IgE-mediated food allergies — the most severe — occur when the body’s immune system mistakenly perceives a food particle as a harmful invader.
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A type of antibody called immunoglobulin E (IgE) contributes to the immune response, which can include stomach issues, itching, hives or anaphylaxis, according to several health experts.
Xolair helps dampen this immune response by targeting certain receptors in the body.
“It is an injection that works on blocking IgE, reducing the risk of an allergic reaction, but needs to be taken regularly to work,” Davis told Fox News Digital.
Research behind the approval
The FDA’s approval decision was based on a study that explored the effectiveness and safety of Xolair in 168 participants ranging from babies to adults.
All participants were allergic to peanuts and at least two other foods, which included milk, wheat, egg, walnut, hazelnut or walnut.
A type of antibody called immunoglobulin E (IgE) contributes to the body’s immune response, which can include stomach issues, itching, hives or anaphylaxis. (iStock)
Participants received either Xolair or a placebo for 16 to 20 weeks.
Sixty-eight percent of those who received Xolair were able to tolerate the equivalent of 2½ peanuts without a moderate or severe allergic reaction, compared to 6% who took the placebo.
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Also among the participants who received the Xolair injections, 67% of people with egg allergies, 66% of people with milk allergies and 42% of people with cashew allergies were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms.
The agency recommended that an individual should only start the medication in a health care setting equipped to manage anaphylaxis.
Patients should discuss with their health care provider whether Xolair is the right choice for them, experts said.
Fox News Digital reached out to the FDA for additional comment.
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The first oral GLP-1 medication for weight loss has been approved for use in the U.S.
The Wegovy pill, from drugmaker Novo Nordisk, was cleared by the Food and Drug Administration to reduce excess body weight, maintain long-term weight reduction and lower the risk of major cardiovascular events.
Approval of the once-daily 25mg semaglutide pill was based on the results of two clinical trials — the OASIS trial program and the SELECT trial.
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The Wegovy pill demonstrated a mean weight loss of 16.6% in the OASIS 4 trial among adults who were obese or overweight and had one or more comorbidities (other medical conditions), according to a press release. In the same trial, one in three participants experienced 20% or greater weight loss.
The first oral GLP-1 medication for weight loss has been approved for use in the U.S. (iStock)
Novo Nordisk reported that the weight loss achieved with the pill is similar to that of injectable Wegovy and has a similar safety profile.
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“With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, president and CEO of Novo Nordisk, in the press release.
Novo Nordisk reported that the weight loss achieved with the pill is similar to that of injectable Wegovy and has a similar safety profile. (James Manning/PA Images via Getty Images)
“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight-loss journey.”
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The oral GLP-1 is expected to launch in the U.S. in early January 2026. Novo Nordisk has also submitted oral semaglutide for obesity to the European Medicines Agency (EMA) and other regulatory authorities.
“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting and constipation,” an expert said. (iStock)
Dr. Sue Decotiis, a medical weight-loss doctor in New York City, confirmed in an interview with Fox News Digital that studies show oral Wegovy is comparable to the weekly injectable, just without the needles.
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Although the pill may result in better compliance and ease of use, Decotiis warned that some patients may not absorb the medication through the gastrointestinal tract as well as with the injectable version due to individual idiosyncrasies in the body.
“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting and constipation,” she said.
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“In my practice, I have found tirzepatide (Mounjaro and Zepbound) to yield more weight loss and fat loss than semaglutide by about 20%,” the doctor added. “This has been shown in studies, often [with] fewer side effects.”
More oral GLP-1s may be coming in 2026, according to Decotiis, including an Orforglipron application by Lilly and a new combination Novo Nordisk drug, which is pending approval later next year.
One expert warned that some patients may not absorb the medication through the gastrointestinal tract as well as with the injectable version. (iStock)
“There will be more new drugs available in the future that will be more effective for patients who are more insulin-resistant and have not responded as well to semaglutide and/or tirzepatide,” the doctor said. “This is great news, as novel drugs affecting more receptors mean better long-term results in more patients.”
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As these medications become cheaper and easier to access, Decotiis emphasized that keeping up with healthy lifestyle habits — including proper nutrition with sufficient protein and fiber, as well as increased hydration — is essential to ensuring lasting results.
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“If not, patients will regain weight and could lose muscle and not enough body fat,” she said.
Fox News Digital reached out to Novo Nordisk for comment.
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A study from Sweden’s Uppsala University discovered a link between microplastics and multiple sclerosis (MS).
The research, published in the journal Environmental International, discovered that exposure to two common environmental contaminants, PFAS and PCBs, could increase the risk of the autoimmune disease.
PFAS, or per- and polyfluoroalkyl substances, known as “forever chemicals,” are used in some common household products, such as non-stick cookware, textiles and cleaning products. They have also been found in drinking water throughout the U.S., according to the U.S. Environmental Protection Agency.
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PCBs, or polychlorinated biphenyls, are toxic industrial chemicals once widely used in electrical equipment before being banned decades ago, as stated by the National Institute of Environmental Health Sciences.
The new study findings were based on blood samples of 1,800 Swedish individuals, including about 900 who had recently been diagnosed with MS, according to a university press release.
PFAS, or per- and polyfluoroalkyl substances, known as “forever chemicals,” are used in some common household products, including non-stick cookware. (iStock)
The first phase of the trial studied 14 different PFAS contaminants and three substances that appear when PCBs are broken down in the body. These were then investigated for a link to the odds of diagnosis.
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“We saw that several individual substances, such as PFOS and two hydroxylated PCBs, were linked to increased odds for MS,” lead study author Kim Kultima said in a statement. “People with the highest concentrations of PFOS and PCBs had approximately twice the odds of being diagnosed with MS, compared to those with the lowest concentrations.”
The researchers then examined the combined effects of these substances and found that the mixture was also linked to increased risk.
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Fellow researcher Aina Vaivade noted that risk assessments should consider chemical mixtures, not just individual exposures, because people are typically exposed to multiple substances at the same time.
“We saw that several individual substances, such as PFOS and two hydroxylated PCBs, were linked to increased odds for MS,” the lead study author said. (iStock)
The final phase of the study investigated the relationship between inheritance, chemical exposure and the odds of MS diagnosis, revealing that those who carry a certain gene variant actually have a reduced MS risk.
However, individuals who carried the gene and had higher exposure to PFOS — a singular type of chemical in the PFAS family — had an “unexpected” increased risk of MS.
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“This indicates that there is a complex interaction between inheritance and environmental exposure linked to the odds of MS,” Kultima said.
“We therefore think it is important to understand how environmental contaminants interact with hereditary factors, as this can provide new knowledge about the genesis of MS and could also be relevant for other diseases.”
Multiple sclerosis is a disease that leads to the breakdown of the protective covering of the nerves, according to Mayo Clinic. (iStock)
Fox News senior medical analyst Dr. Marc Siegel commented on these findings in an interview with Fox News Digital.
“MS is a complex disease that is somewhat autoimmune and somewhat post-inflammatory,” said Siegel, who was not involved in the study. “Epstein-Barr virus infection greatly increases the risk of MS.”
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“There is every reason to believe that environmental triggers play a role, including microplastics, and this important study shows a correlation, but not causation — in other words, it doesn’t prove that the microplastics caused MS.”
The study had some limitations, the researchers acknowledged, including that the chemical exposure was measured only once, at the time of blood sampling. This means it may not accurately represent participants’ long-term or past exposure levels relevant to MS development.
“There is every reason to believe that environmental triggers play a role.”
Fox News Digital reached out to several industry groups and manufacturers requesting comment on the potential link between PFAS chemicals and multiple sclerosis.
Several have issued public statements, including the American Chemistry Council, which states on its website that “manufacturers and many users of today’s PFAS are implementing a variety of practices and technologies to help minimize environmental emissions.”
In April 2024, the EPA enacted a new federal rule that sets mandatory limits on certain PFAS chemicals in drinking water, aiming to reduce exposure. The agency also aims to fund testing and treatment efforts.
A woman working out outdoors takes a sip of water from a plastic bottle. (iStock)
Multiple sclerosis is a disease that leads to the breakdown of the protective coverings that surround nerve fibers, according to Mayo Clinic.
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The immune system’s attack on these nerve sheaths can cause numbness, weakness, trouble walking and moving, vision changes and other symptoms, and can lead to permanent damage.
There is currently no cure for MS, Mayo Clinic reports, but treatment is available to manage symptoms and modify the course of the disease.
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