Itepekimab

Non-cystic fibrosis bronchiectasis market driven by rising prevalence, early diagnosis, and drug development. Over 15 companies, including Zambon SpA, Insmed, and AstraZeneca, are developing 15+ pipeline therapies. Key drugs in trials include Colistimethate sodium, Benralizumab, and Brensocatib.

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

Regeneron and Sanofi won FDA approval for Dupixent in COPD, targeting 300,000 U.S. adults with eosinophilic phenotype. GlobalData forecasts $6.57 billion in 2033 sales, while Sanofi and BMO Capital Markets predict $5.5 billion and $2.5 billion respectively. Competitors AstraZeneca, GSK, and Roche have ongoing trials for their biologics in COPD. Regeneron and Sanofi aim to establish market presence before rivals launch.

COPD treatment advances include precision medicine, biologics like dupilumab, biomarkers for early diagnosis, remote monitoring, omics tech, and regenerative medicine, promising more personalized and effective care.

FDA approves Dupixent for COPD, making it the first biologic medicine for the condition in the U.S. This expansion is expected to boost sales, which reached almost $12 billion globally last year. Dupixent targets Type 2 inflammation in a subset of COPD patients, showing reduced exacerbations and improved lung function in trials. European regulators approved Dupixent for COPD in July, but U.S. approval required additional efficacy data. The approval comes as Regeneron faces market value loss due to a court case, increasing pressure on its pipeline.

AERIFY-1 and AERIFY-2 are phase 3 trials evaluating itepekimab, an anti-IL-33 monoclonal antibody, in former smokers with moderate-to-severe COPD. These studies aim to confirm itepekimab's efficacy in reducing exacerbations and improving lung function, as observed in a phase 2 study, with a focus on safety and symptomatic benefits over 52 weeks.