AstraZeneca’s tozorakimab is the first biologic to demonstrate statistically significant efficacy in reducing moderate and severe COPD exacerbations in a broad population of patients who continued to experience exacerbations while receiving inhaled standard-of-care therapy.
Tozorakimab reduced moderate and severe COPD exacerbations among former smokers by 29% in Oberon and 34% in Titania, according to a Sept. 8 AstraZeneca news release. Among current and former smokers, the reductions were 30% and 29%, respectively.
A pooled analysis found reductions across blood eosinophil thresholds. Patients with a baseline count of less than 150 had a 23% reduction in moderate and severe exacerbations, compared with 34% among those with counts of 150 or higher and 43% among those with counts of 300 or higher.
The phase 3 trials included 2,306 patients who received tozorakimab 300 mg once every four weeks or placebo over 52 weeks, on top of inhaled therapy. The drug was generally well tolerated, with injection-site reactions as the only adverse drug reaction.
The FDA has accepted tozorakimab for priority review as an add-on maintenance treatment for adults with COPD. The Prescription Drug User Fee Act date is anticipated in the first quarter of 2027.
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