Common side effects observed during trials included upper respiratory infection, headache, and rash, highlighting the need for careful patient monitoring.

Insmed Incorporated, the manufacturer, is well-positioned to facilitate market penetration and patient access due to its existing commercial infrastructure.

The approval opens new investment opportunities in respiratory therapeutics, as Brinsupri enters a previously untapped market with no existing approved therapies.

This approval establishes brensocatib as the first dipeptidyl peptidase 1 (DPP1) inhibitor authorized for treating a neutrophil-mediated disease, offering a novel approach to managing bronchiectasis.

In Phase 3 clinical trials, brensocatib demonstrated a reduction in annual exacerbation rates by up to 21% and slowed lung function decline, particularly in patients taking the 25 mg dose.

Brensocatib, marketed as Brinsupri, has received FDA approval as the first treatment for non-cystic fibrosis bronchiectasis, marking a significant advancement for patients suffering from this chronic lung condition.

The drug works by specifically targeting neutrophilic inflammation, a key factor in the progression of bronchiectasis, which affects approximately 500,000 individuals in the U.S.

The ASPEN trial, the largest clinical trial for bronchiectasis, showed that annualized exacerbation rates were significantly lower in those receiving brensocatib compared to the placebo group.

International regulatory submissions are underway, with plans for market expansion in Europe and Asia, where bronchiectasis prevalence is higher.

Insmed aims to seek approval for Brinsupri in Europe, the United Kingdom, and Japan, with anticipated commercial launches in 2026.

Doreen Addrizzo-Harris, M.D., emphasized that Brinsupri addresses a root cause of bronchiectasis exacerbations, potentially setting a new standard for treatment.

Experts believe this approval represents a paradigm shift in bronchiectasis treatment, providing hope for improved quality of life for patients.