For nearly 20 years, the drug Xolair, or omalizumab, has been approved by the FDA to help patients with asthma and chronic hives. Now, the FDA has added protection for people with severe food allergies to the drug’s list of potential uses.
For nearly 20 years, the drug Xolair, or omalizumab, has been approved by the FDA to help patients with asthma and chronic hives. Now, the FDA has added protection for people with severe food allergies to the drug’s list of potential uses.
“Essentially, we’re in a sense repurposing that drug, the use of that drug, for the prevention of food allergic reactions from small, accidental exposures,” said Dr. Rachel Shriver. Stated. schreiber allergy in Rockville.
Schreiber said the drug can now be prescribed to slightly increase a patient’s tolerance in case of accidental exposure to small amounts of food that can normally cause anaphylaxis.
“Let’s say it takes half a peanut to react. This drug might raise that threshold to three peanuts,” she says.
But she warns that this is not a cure and that even people with known food allergies should always carry an EpiPen.
Even before the FDA’s decision, it was well known in the medical community that the drug could help people with food allergies. The problem was that insurance coverage for the expensive drugs was rare because of their off-label use. Schreiber said Xolair’s treatment could cost nearly $35,000.
“You might have been able to use it that way before, but now that it’s (FDA) approved, patients will be covered,” she said.
It is given as an injection every two to four weeks, Shriver said. In the future, there may be a version that can be taken at home, but for now it must be administered at a doctor’s office, she said. Even with the home version, patients need to take the drug at a doctor’s office for several doses, as side effects have been reported.
“Ironically, this drug has a black box warning for anaphylaxis,” Schreiber said.
Also, not all people with food allergies will benefit from this drug. To get a prescription, you will need a blood test to see if your body responds to an allergic reaction by producing antibodies called immunoglobulin E or IgE.
Shriver warned that even if the drug were approved for use, there would be delays in coverage as insurance companies update their systems to allow coverage.
Schreiber said patients have been calling her office since the FDA’s announcement and are “really excited” about the possibility of new protection against foods they are allergic to.
“I think this is a huge step forward in treating food allergies,” Schreiber said.
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