Zam Stream
TOPLINE
The U.S. Food and Drug Administration approved the use of Xolair to reduce the severity of allergic reactions to one or more foods, making it the first FDA-approved medication to treat allergic reactions to multiple foods from accidental exposure.
KEY FACTS
The FDA approved the injectable drug—which is developed and co-promoted in the U.S. by Novartis Pharmaceuticals and Genentech—for use in patients aged one year and older with immunoglobulin E (IgE)-mediated food allergies who are accidentally exposed to one or more foods that could trigger a reaction.
Patients can take the drug every two to four weeks—depending on several factors— to tolerate higher amounts of allergens without severe reactions when accidentally exposed, the Associated Press reported.
Though repeated use benefits patients, the FDA said they must continue avoiding foods they are allergic to, and the drug is not approved for “immediate emergency treatment” of such reactions, including anaphylaxis, according to the agency.
In a statement, Novartis executive Reshema Kemps-Polanco said the approval “represents a paradigm shift” in the management of food allergies.
The agency approved the drug based on safety and efficacy data from the Phase 3 OUtMATCH study, which evaluated the medication in 168 patients aged 1 to 55 with allergies to peanuts and at least two other foods, including milk, wheat and cashews.
CRUCIAL QUOTE
“Patients who take this medication must continue to avoid foods they are allergic to,” the FDA said in a post on X. “The injection is not approved for the immediate emergency treatment of allergic reactions.”
TANGENT
On Wednesday, the agency approved Aurlumyn, the first medication to treat severe frostbite.
KEY BACKGROUND
Xolair was originally approved by the FDA in 2003 to treat “moderate to severe persistent allergic asthma” in patients aged 12 and older, according to the agency. The medication is also used to treat certain patients with chronic spontaneous urticaria, or chronic hives, and chronic rhinosinusitis with nasal polyps. According to Genentech data, Xolair has been used by more than 700,000 patients in the U.S. since its initial approval. It was granted priority review by the FDA in December.
