Medical Innovation Exchange

Novartis suffers shock setback as Xolair successor fails phase 3

Novartis’ attempt to establish ligelizumab as the successor to its blockbuster Xolair has hit a roadblock. The new molecule failed to better the old stager in a phase 3 clinical trial, leaving Novartis uncertain of its next steps for the program.

Ligelizumab, a high-affinity anti-IgE antibody, beat placebo in the two phase 3 clinical trials of patients with the skin condition chronic spontaneous urticaria. However, the drug was no better than Xolair on a urticaria scoring system. Novartis is yet to share data from the study, but the headline failure is a major blow for a drug designed to take up the mantle from the Roche-partnered Xolair.

The failure to show superiority versus Xolair was “contrary to widespread expectations,” analysts at Jefferies wrote in a note to investors. The analysts forecast peak worldwide ligelizumab sales of $1.5 billion at 70% probability.

Novartis is still going over the data from the two phase 3 studies and plans to hold off on sharing the full results until it completes the trials in the second half of next year. The Swiss Big Pharma plans to provide an update on the next steps for ligelizumab “in due course.” John Tsai, M.D., chief medical officer at Novartis, expressed disappointment in the results and vowed to continue evaluating ligelizumab in other diseases.

RELATED: Novartis’ Xolair follow-up banishes hives in 42% of patients

Tsai named the inflammatory skin condition chronic inducible urticaria and food allergy as areas in which Novartis still sees a future for ligelizumab. Novartis began a phase 3 clinical trial in chronic inducible urticaria. A phase 3 study in patients with peanut allergy has an estimated start date of Dec. 10 on, but at the time of writing is still listed as not yet recruiting.

If ligelizumab is limited to those indications, Novartis still has a shot at bringing a new drug to market in the skin condition chronic spontaneous urticaria. The other drug, remibrutinib, is a BTK inhibitor Novartis moved into phase 3 in the disease in September. Novartis’ remibrutinib studies lack an active control.


Nick Paul

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