pharmaphorum February 19, 2024
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.
The FDA has cleared the use of the IgE inhibitor to reduce allergic reactions, including life-threatening anaphylaxis, that can occur with accidental exposure to foods in adult and paediatric patients aged one year and older who have one or more IgE-mediated food allergies, which include peanut, milk, egg, wheat, cashew, hazelnut, and walnut.
Interim analysis results from the phase 3 OUtMATCH study showed that Xolair (omalizumab) significantly increased the amount of peanut, milk, egg, and cashew that it took to cause an...