FDA committee votes to approve peanut allergy treatment that had clinical trials at National Jewish Health

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DENVER — There is new hope for 1.6 million kids who suffer from life-threatening peanut allergies. A U.S. Food and Drug Administration committee voted to approve the first-ever peanut allergy treatment, and National Jewish Health in Denver participated in the clinical trials.

The new treatment is called Palforzia. It’s an oral immunotherapy designed to slowly desensitize a young patient’s immune system to peanuts. If approved, it could be available to kids aged 4 to 17.

The vote is good news to the Hinckley family. Three-year-old Vivian has a peanut allergy.

“That can be difficult and stressful. So, I think anything that can help alleviate that problem a little bit — even if it’s not a cure — is still a positive,” said Rob Hinckley, Vivian’s father.

The goal of the treatment is to expose young patients to small amounts of peanut protein. Doctors could increase the dose over time in order to build up a tolerance.

To start, patients would have to go into a clinical setting to be administered the treatment. Then, at a certain point, they would have to take the maintenance dose at home every day.

The hope is this treatment could limit a reaction if a child was accidentally exposed. In trials, the treatment was effective for the majority of patients.

Dr. BJ Lanser, a pediatric allergist at National Jewish Health, ran one part of the clinical trial.

“It’s the first option we have for the treatment of food allergies, so from that standpoint, absolutely this is a big deal. This is groundbreaking,” he said. “This is a big deal, but with this caveat that this is not an easy, simple cure and the therapy isn’t going to be for everyone,” Lanser said.

Some patients experienced side effects like mouth itching and stomach problems, and there is always a possibility of a more serious reaction.

“It’s an exciting opportunity and it represents a good option for some people. But it’s a very important conversation for folks to have with their allergist about whether this treatment is right for them. Everybody needs to be fully aware of what the risks and side effects are, and what the true goal or outcome is,” Lanser said.

The treatment could get final FDA approval in the coming months. The therapy is expected to cost several thousand dollars a year and insurance coverage is not yet known.

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