FAHF-2 is safe, and inhibits basophils in food allergic patients

Published Online: July 18, 2011

Food allergy is of increasing health concern in westernized countries. Development of safe and effective interventions for food allergy is needed. The USFDA investigational new botanical drug food allergy herbal formula-2 (FAHF-2), an extract of nine Traditional Chinese Medicinal herbs, blocks peanut anaphylaxis in a murine model of peanut allergy. FAHF-2 is the first investigational new drug for food allergy.

In a recent issue of The Journal of Allergy and Clinical Immunology (JACI), Patil et al report clinical safety results of a 6 months open-label study of FAHF-2 and effects on basophils. No significant drug-associated abnormalities in laboratory parameters, pulmonary function studies, or electrocardiographic findings before and after treatment were found. There was a significant reduction (p< 0.05) in basophil CD63 expression in response to ex vivo stimulation and a trend of reduced percent of circulating basophils and eosinophils after 6 months of FAHF-2 treatment.

It was concluded that FAHF-2 was safe, well-tolerated, and had an inhibitory effects on basophils. A controlled phase II study is warranted.


The Journal of Allergy and Clinical Immunology (JACI) is the official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.

AAAAI - American Academy of Allergy Asthma & Immunology