On February 16th, 2024, Genentech announced in a press release that the U.S. Food and Drug Administration (FDA) granted approval of a new indication for the biologic injection Xolair® (omalizumab) to be prescribed to both adult and pediatric patients to mitigate allergic reactions to certain foods.
As described in the release, research found that patients taking Xolair for allergies related to peanuts, milk, eggs, cashews, and other foods were able to better tolerate these common foods. These findings are a breath of fresh air to the millions of patients who suffer from IgE-mediated food allergies.
IVX Health already serves pediatric patients with severe allergies who’ve been prescribed Xolair or other biologic by their referring allergist or immunologist. IVX Health is now accepting new patients being prescribed Xolair injections for food allergies for administration in all of its nearly 100 centers across the country.
As many of these new Xolair prescriptions will be written for pediatric patients, IVX Health also has a Pediatric Advance Life Support (PALS) certified nurse in each of its markets to ensure the health and safety of our younger patients. And since referring specialists will likely desire for their patients to remain in a clinical facility for an observation period after their first several doses, IVX Health offers a world-class patient experience, where patients and families can relax in a guaranteed private suite.
Here are a few additional details from the announcement.
Overview
Genentech recently announced a groundbreaking FDA approval for Xolair (omalizumab), the first medicine to reduce allergic reactions in children (aged 1 and up) and adults with IgE-mediated food allergies. The approval follows promising results from the NIH-sponsored OUtMATCH study.
Key Points
- Xolair enables patients as young as 1 to tolerate small amounts of peanuts, milk, egg, and cashew without allergic reactions.
- Over 40% of kids and more than half of adults with food allergies have faced severe reactions.
- FDA approval is based on positive data from the Phase III OUtMATCH study, which assessed Xolair’s effectiveness in patients allergic to peanuts and at least two other food allergens.
Why It Matters
- Xolair provides a crucial treatment option to manage food allergies and reduce serious reactions.
- Food allergies are a leading cause of anaphylaxis – a severe, life-threatening allergic reaction that can happen in seconds or minutes causing the body to go into shock. Anaphylaxis can lead to severe injury or even death if not treated immediately.
- Food allergies can also be a major disruption for adults, children, and parents, as one’s quality of life can be affected by the diet limitations caused by food allergies.
The Impact
- Over 3.4 million children and 13.6 million adults in the U.S. suffer from IgE-mediated food allergies.
- Food allergies have been on the rise, with reactions ranging from mild to severe, impacting thousands yearly.
What is Xolair?
- Xolair is a prescription biologic medicine administered as an injection under the skin.
- Xolair operates by blocking the attachment of immunoglobulin E (IgE) to its specific receptor found on mast cells and basophils. By preventing this interaction, Xolair effectively reduces the activation of these cells, which play a critical role in allergic reactions. Consequently, this leads to a decrease in the symptoms associated with these conditions, improving patient outcomes.
- Along with the new indication for food allergies, Xolair has been approved for the treatment of severe persistent asthma in patients six years and older and also for patients with chronic idiopathic urticaria aged 12 years and older.
- Xolair has been approved for use since 2003 and has benefited over 700,000 patients.