Drugs

AstraZeneca Reports Positive Data on COPD Biologic

AstraZeneca says data from the Phase 3 OBERON and TITANIA trials showed that tozorakimab is the first biologic to demonstrate statistically significant efficacy in reducing moderate and severe exacerbations in a broad population of patients with chronic obstructive pulmonary disease (COPD) still experiencing exacerbations while on inhaled standard of care.

“Tozorakimab 300mg, administered once every four weeks, demonstrated a reduction in moderate and severe COPD exacerbations in the primary population of former smokers by 29% (OBERON) and 34% (TITANIA), and in the overall population of current and former smokers by 30% (OBERON) and 29% (TITANIA) compared with placebo while on inhaled standard of care,” the company says. “In a pooled analysis of OBERON and TITANIA, tozorakimab also demonstrated clinically meaningful reductions in moderate and severe exacerbations in all prespecified patient subgroups…,” it adds.

Tozorakimab was also generally well tolerated with a favorable safety profile. The only adverse drug reaction was injection-site reaction, according to AstraZeneca.

A BLA for tozorakimab 300mg has been accepted for priority review as an add-on maintenance treatment for adult patients with COPD. The user fee review action target date is expected during the first quarter of 2027 following use of a priority review voucher, the company says.

Tozorakimab is described as a first-in-class potent human immunoglobulin monoclonal antibody that binds to interleukin-33 (IL-33). It is designed to target the “top of the inflammatory cascade uniquely inhibiting IL-33 signalling in two ways, thereby suppressing inflammation and disrupting the cycle of mucus dysfunction," AstraZeneca says.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome