Roche Touts Food Allergy Drug As Superior Than Oral Immunotherapy

Roche Holdings AG RHHBY released data Sunday on its Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH study for Xolair (omalizumab) for one or more food allergies.

Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.

• In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group.
• These findings were largely driven by the high rates of adverse events (AEs) in the OIT group.
• Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%), and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.

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Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient’s diet after stopping Xolair.

Stage 3 is ongoing, and study investigators continue to analyze data from additional patients who completed Stage 2 and then entered Stage 3.

In the US, Genentech, a member of the Roche Group, and Novartis AG NVS are co-developing and co-promoting Xolair.

Last February, the FDA approved Xolair for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

Price Action: RHHBY stock closed at $41.74 on Friday.

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