Xolair Approved for Reducing Allergic Reactions

FDA has approved a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged one year and older with Immunoglobulin E (IgE)-mediated food allergy.

Approval is based on data from the Phase 3 OUtMATCH study, which showed a “statistically significant higher proportion of patients (68%) treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo (p<0.0001),” the company says. In addition, a statistically significant higher proportion of patients treated with Xolair compared to placebo tolerated at least 1,000 mg of protein from milk (66% vs. 11%; p<0.0001), egg (67% vs. 0%; p<0.0001) or cashew (42% vs. 3%; p<0.0001) without moderate to severe allergic symptoms.”