FDA Approves Xolair for Multiple Food Allergy Relief

(CTN News) – The US Food and Drug Administration authorised Xolair, a medicine that reduces the intensity of allergy reactions in those who are allergic to various foods.

Xolair, developed and co-marketed by Genentech and Novartis in the United States, was first licenced in 2003 for the treatment of moderate to severe persistent allergic asthma in select patients.

Xolair, also known as omalizumab, is administered via injection in doses ranging from 75 mg to 600 mg every 2 to 4 weeks by a healthcare provider or self-injection at home, according to Novartis. A patient’s weight determines the dosage and frequency of administration.

The FDA reports that using the medicine on a regular basis can lower the risk of allergic reactions, including anaphylaxis, in people and children as young as one year who have been accidentally exposed to foods including peanuts, milk, eggs, and wheat.

However, Xolair “is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis,” according to the FDA.

Anaphylaxis is a severe allergic reaction that requires prompt medical attention, including epinephrine injections.

The FDA emphasises that Xolair patients should continue to avoid items that cause allergic reactions.

“This newly approved use of 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 Centre 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.”

“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 describes the newly approved usage of Xolair as a new tool for controlling life-threatening food allergies.

The FDA granted permission based on a Phase 3 placebo-controlled research. According to the FDA, researchers studied 168 individuals aged 1 to 55 who were allergic to peanuts and at least two additional dietary allergens, such as milk, egg, wheat, cashew, hazelnut, or walnut.

“The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrammes 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 individuals who got Xolair, 68% were able to ingest a single dosage of peanut protein without experiencing moderate to severe allergy symptoms such as whole-body hives, persistent coughing, or vomiting, compared to 6% who received a placebo.

However, results suggest that 17% of patients who got the drug experienced no significant change in their tolerance for peanut protein.

The FDA states that Xolair has been associated with adverse effects such as injection site reactions 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 Food and Drug Administration (FDA) states.

In 2021, about 6% of the US population had a food allergy that could cause life-threatening reactions, as reported by the US Centres for Disease Control and Prevention.

Food allergies are currently incurable, according to health professionals.

“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,” stated Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America.

“Given the rising frequency of food allergies, this revelation provides hope to the many children and adults who could benefit from a novel strategy to manage their allergies.