The TPIRC Difference for OIT
 

Last month, the FDA released a Briefing Document (link below) outlining a few limitations in the application of the standard clinical trial model to food allergy treatment such as oral immunotherapy (OIT). For example, the FDA notes that “subjecting severely food-allergic individuals to multiple OFCs [oral food challenges] entails risk to the study subjects and recruitment challenges for study sponsors.” The FDA suggests that alternative models should be considered when evaluating OIT and other treatment options for food allergy.

Additionally, the FDA document notes that “[t]olerance has not been demonstrated in any controlled trial of food AIT [allergen immunotherapy, including OIT] to date.” This should not be conflated with any conclusion about the efficacy of OIT generally. It simply refers to the limitations of clinical trials, which typically require 4 phases of study before FDA approval eligibility, a process that can take 10 years or longer and is achieved only 25% of the time. No food allergy treatment has completed a phase 3 or a phase 4 trial. It’s not surprising, therefore, that clinical trials have not yet demonstrated tolerance. We have not had 10 plus-year studies to truly test that model.

It also should be noted that the FDA “does not approve medical foods” as therapy. As a result, FDA policy likely precludes OIT from ever resulting in FDA approval. Lack of FDA approval does not disqualify OIT as a valid and appropriate treatment, however. Many safe and effective medical treatments lack FDA approval yet still are widely used, including allergy shots.

TPIRC’s unique structure addresses the concerns voiced by the FDA. TPIRC’s OIT program is not a clinical trial. Rather, TPIRC integrates research, patient-specific clinical care, and advocacy. TPIRC doctors have nearly a decade of experience in OIT and have achieved an unmatched 99% success rate. Its nearly 1,000 OIT patients have achieved larger maintenance doses than those following other protocols, including more than 300 peanut graduates safely eating at least 60 peanuts daily. The goal of TPIRC’s protocol is to induce immunological tolerance, where IgE = Zero. In fact, there are hundreds of patients whose IgE based numbers have decreased to 0 for various foods and as a result no longer need to ingest these foods on a regular basis. We are demonstrating that food allergy patients can develop desensitization which can drive toward tolerance in a safe, effective, and user-friendly model.

Stay tuned for upcoming news about our doctors’ innovative approach!

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/UCM482114.pdf

 

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