WASHINGTON — The US Food and Drug Administration on Friday approved a medication called Xolair to help lessen the severity of an accidental allergic reaction in people who are allergic to multiple foods.
Xolair, which is developed and co-promoted by Genentech and Novartis in the US, was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients.
Omalizumab, the generic name for Xolair, is given by injection in 75 mg to 600 mg doses once every 2 or 4 weeks by a health care provider or at home through self-injection, according to Novartis. Dose and dosing frequency is determined by a patient’s weight.
Repeated use of the medication can help reduce the risk of allergic reactions, such as anaphylaxis, in certain adults and children as young as 1 year following accidental exposure to foods such as peanuts, milk, egg, and wheat, according to a news release from the FDA.
However, Xolair, “is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis,” the FDA said.
Anaphylaxis is a serious and sometimes life-threatening allergic reaction which requires immediate medical treatment, including an epinephrine injection.
Xolair patients must continue to avoid foods they are allergic to, the FDA stresses.
“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,” said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research.
“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.”
For food allergy treatment, the estimated list price for Xolair ranges from approximately $2,900 for children and $5,000 for adults each month, according to Genentech.
“The actual cost paid by most patients is typically lower based on their insurance coverage and other financial assistance programs available,” Lindsey Mathias, a spokesperson for Genentech, told CNN on Monday.
Meanwhile, the monthly cost for Xolair will also vary from person to person depending on a number of factors including a patient’s body weight and dose.
“Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result,” said Reshema Kemps-Polanco, executive vice president and chief commercial officer of Novartis US.
Novartis says the newly approved use of Xolair is a new tool in managing often life-threatening food allergies.
The FDA approval was based on a Phase 3, placebo-controlled study. Researchers looked at 168 patients ages 1 to 55 who were allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut, according to the FDA.
“The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrams or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms, such as moderate to severe skin, respiratory or gastrointestinal symptoms, at the end of the 16-to-20-week treatment course.”
Of the patients that received Xolair, 68% were able to eat the single dose of peanut protein without moderate to severe allergic symptoms such as whole-body hives, persistent coughing, or vomiting, compared to 6% of patients who received the placebo.
However, 17% of subjects who received the medication had no significant change in the amount of peanut protein tolerated, data shows.
Xolair does come with observed side effects, the FDA notes, including reactions at the injection site, and fever. “Xolair comes with certain warnings and precautions, such as anaphylaxis, malignancy, fever, joint pain, rash, parasitic (worm) infection and abnormal laboratory tests,” the agency says.
According to the US Centers for Disease Control and Prevention, almost 6% of people in the United States in 2021 had a food allergy that could lead to a potentially life-threatening reaction.
Currently, there is no cure for food allergies, health officials note.
“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,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America. “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.”
The-CNN-Wire
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