For close to two decades the drug Xolair or omalizumab has been FDA approved to help people with Asthma or chronic hives. Now, the FDA has added to the list of potential uses for the drug: protecting people with severe food allergies.
For close to two decades the drug Xolair or omalizumab has been FDA approved to help people with Asthma or chronic hives. Now, the FDA has added to the list of potential uses for the drug: protecting people with severe food allergies.
“Essentially, we’re sort of repurposing the drug, the use of the drug, for prevention of food allergy reactions to a small amount of accidental exposure,” said Dr. Rachel Schreiber with Schreiber Allergy in Rockville.
The drug can now be prescribed to boost a person’s tolerance just a little, in case of accidental exposure to small amounts of the foods that normally can cause anaphylaxis, Schreiber said.
“Let’s say it would take someone half a peanut to react, maybe this drug raises that threshold to like three peanuts,” she said.
But she cautions it is not a cure, and people who know they have food allergies still need to always have an EpiPen with them.
It was well known in the medical community, before the FDA decision, that the drug can help food allergy sufferers. The problem, with off-label use, insurance coverage for the expensive drug was rare. The cost for Xolair treatment can go for nearly $35,000, according to Schreiber.
“It could have been used in that way in the past, but now it has (FDA) approval and so we will be able to get our patients covered,” she said.
It’s administered as an injection every two to four weeks, according to Schreiber. While a version that could be taken at home could be available in the future, she said right now it must be administered in a doctor’s office. Even with an at-home version, patients would still need to take the medicine in a doctor’s office for the few doses, due to one reported side effect.
“There is a black box warning on this drug for ironically anaphylaxis,” Schreiber said.
Also, not everyone with food allergies will benefit from the drug. Getting it prescribed will require bloodwork to see if a patient’s body responds to allergic reaction by producing antibodies called Immunoglobulin E or IgE.
Schreiber cautions that even though approval has been granted to use the drug in this way, there will be a delay in getting it covered as insurance companies update their systems to allow it to be covered.
Schreiber said patients have been calling her office since the FDA announcement and “are really excited” about the new potential protection against the foods to which they are allergic.
“I think it really is a big step forward in the treatment of food allergy,” said Schreiber.
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