Will Xolair Become Obsolete in the Treatment of Allergies?

Implications: This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant potential to replace omalizumab as effective anti-IgE therapy with just one dose, even in patients with very high initial levels of total IgE. The potential market share for such a treatment is enormous since at least 25% of the population suffers from Ige-mediated diseases such as allergic rhinitis, asthma, atopic eczema, and food allergy.

Analysis: The volume of use of Xolair has been disappointing for Genetech and Novartis. Some reasons include difficulty receiving approval for multiple indications, the narrow range of IgE levels which qualify for treatment, and significant administrative and cost issues plaguing Xolair usage. If this newer monoclonal anti-IgE mAb12 shows continued promise in future clinical trials, its potential for overall market share and the negative impact on Xolair could be dramatic.