8th Sep 2026 14:21
(Alliance News) - AstraZeneca PLC on Tuesday said its biologics licence application for tozorakimab in the US was accepted under priority review.
The Cambridge, England-based pharmaceutical company said the Food & Drug Administration review approval is for patients with chronic obstructive pulmonary disease.
The company said it expects the FDA to complete its review in the first quarter of 2027. Tozorakimab is currently under regulatory review for the treatment of COPD in several markets, including the EU and China.
The company said phase 3 trial results showed that tozorakimab, a monoclonal antibody, showed "statistically significant and highly clinically meaningful efficacy in reducing moderate and severe exacerbations in a broad population of patients with COPD still experiencing exacerbations while on inhaled standard of care."
AstraZeneca said 300 milligrammes of tozorakimab administered once every four weeks showed a reduction in the primary population of former smokers in moderate and severe COPD exacerbations by 29% in one phase 3 trial, and by 34% in another phase 3 trial.
In the overall population of current and former smokers, the reductions were of 30% and 29%, compared with placebo while on inhaled standard of care.
Sharon Barr, executive vice president of BioPharmaceutical research & development at AstraZeneca, said: "Today's groundbreaking tozorakimab results, from two replicate trials, set a new standard for COPD treatment outcomes in a broad population of patients. AstraZeneca has clinically validated the novel approach of targeting the signalling of the two forms of interleukin-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction. With our FDA priority review, we look forward to bringing this treatment to patients as quickly as possible."
Separately, AstraZeneca announced that Imfinzi plus Amgen Inc's Imdelltra in a phase 3 trial showed a statistically significant and "highly clinically meaningful" improvement in overall survival and progression-free survival in first-line extensive-stage small cell lung cancer.
The improved overall survival rate is in comparison with Imfinzi alone as a first-line maintenance treatment.
Imfinzi and Imdelltra, the latter developed by Thousand Oaks, California-based Amgen, are immunotherapies.
AstraZeneca's Sharon Barr said: "These results show that Imfinzi-based induction therapy followed by maintenance treatment with Imfinzi plus tarlatamab demonstrates an unprecedented improvement in overall survival for patients with this highly aggressive form of lung cancer. Imfinzi continues to reshape how lung cancer is treated, establishing new standards of care across multiple settings, and these new findings further underscore its role as the backbone immunotherapy of choice for small cell lung cancer."
AstraZeneca shares were 0.1% higher at 12,056.75 pence each on Tuesday afternoon in London, while Amgen shares traded 5.9% lower at USD411.50 in pre-market trading in New York.
By Tom Budszus, Alliance News slot editor
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