Food Allergies

Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.

The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.

Safety findings from the phase 3 OUtMATCH trial were notable, including no adverse events for omlizumab vs 30.5% for OIT and epinephrine use for 0% vs 37.3%, respectively.

Participants (aged 6 to 17 years) receiving neffy vs standard treatments had fewer skin, gastrointestinal, and respiratory symptoms at 15, 5, and 5 minutes, respectively.

AAAAI 2025: Dupilumab was associated with a 56.9% reduction in IgE levels at 12 months and of 73.5% at 24 months, according to results presented at AAAAI 2025.

AAAAI 2025: Phase 2 study results showed POIT with home-measured peanut products was not only highly effective but also posed few risks.

In a randomized clinical trial, omalizumab achieved a 36% treatment success rate for multi-food allergy compared with 19% for oral immunotherapy.

If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.