Novartis' Xolair follow-up banishes hives in 42% of patients with chronic hives

Two doses of Novartis’ new treatment for chronic hives cleared the skin of more patients than Xolair, its Roche-partnered asthma drug that scored approval for the skin condition in 2014. The highest dose of the drug, ligelizumab, banished hives in 51% of patients, compared to 26% of patients taking Xolair. 

The phase 2b study tested ligelizumab, an antibody that targets the IgE/FceR1 pathway, patients with chronic spontaneous urtucaria (CSU), or chronic hives, who couldn’t control their symptoms with the standard of care, H1-antihistamines. 

It randomized nearly 400 patients to receive a 300 mg dose of Xolair (omalizumab), one of three doses of ligelizumab—24 mg, 72 mg or 240 mg—or placebo. After 12 weeks of treatment, 42% of patients taking the 72 mg dose and 51% of those on the 240 mg dose had “complete control” of their symptoms, versus 26% of patients taking Xolair and zero patients on placebo. 

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The findings appear in The New England Journal of Medicine. 

“Around half of patients on current standard-of-care treatment, including omalizumab, for CSU continue to have uncontrolled symptoms,” said Eric Hughes, who leads the immunology, hepatology and dermatology unit at Novartis, in a statement. “We’re encouraged by the results of this study, which is a step forward in our journey to reimagine care in immuno-dermatology to bring better treatment options for patients.” 

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First approved in 2003 and then cleared for chronic hives in 2014, Xolair has become a reliable moneymaker for Roche and Novartis, raking in $1.75 billion in U.S. sales last year. With a key patent for Xolair expiring last year, Novartis is pushing ligelizumab to be its successor. 

Novartis moved ligelizumab into a pair of phase 3 studies that will test it in more than 2,000 patients last December. They will be the largest pivotal trials to date in the disease.