AstraZeneca Says Asthma Drug Failed Trial In Smoker’s Disease

The company stated that the safety and tolerability of the drug in the recent trial were consistent with the known profile of the medicine, and added that it will analyze the data further to understand the results.

AstraZeneca (AZN) announced on Wednesday that its late-stage trial of Fasenra in patients with chronic obstructive pulmonary disease (COPD) did not achieve statistical significance in the primary endpoint of controlling flare-ups.

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COPD, also called Smoker’s Disease, is a debilitating, irreversible, and progressive disease whose exacerbations are life-threatening and can cause irreversible lung damage and even death. According to AstraZeneca, it affects 391 million people globally.

The safety and tolerability of the drug in the recent trial were consistent with the known profile of the medicine. The company stated that it will analyze the data further to understand the results.

Shares of the company slipped 0.3% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around AZN stock fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours, while message volume fell from ‘normal’ to ‘low’ levels.

AZN’s Sentiment Meter and Message Volume as of 7:28 a.m. ET on Sept. 17, 2025 | Source: Stocktwits

The study was aimed at evaluating the efficacy and safety of 100 mg of Fasenra in people with moderate to very severe COPD with a history of frequent COPD exacerbations and an elevated blood eosinophil count. The company enrolled patients in the trial with a history of at least two COPD exacerbations in the year before enrollment and who were current or former smokers. Patients were randomized to receive either a placebo or Fasenra while remaining on their existing therapy.

“COPD, which remains a leading cause of death worldwide, is a complex, heterogeneous disease and we continue to advance other promising approaches in our pipeline to address the unmet needs of patients,” company executive Sharon Barr said

Fasenra is already used to treat severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis in several countries. According to AstraZeneca, over 150,000 patients worldwide are currently taking Fasenra. In the first half of 2025, Fasenra generated $920 million in revenue, representing an 18% year-over-year increase.

Separately, the company also announced that its late-stage trial evaluating subcutaneous Saphnelo in patients with systemic lupus erythematosus (SLE) met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in disease activity compared to placebo. SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body. It is estimated to impact over 3.4 million people globally.

AZN stock is up by 18% this year and down by about 1% over the past 12 months. 

Read also: X4 Pharma To Halve Headcount Amid Efforts To Complete Neutropenia Trial

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