Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

Brinsupri, developed by Insmed, has received FDA approval as the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB), a progressive lung disease affecting around 500,000 U.S. patients135.

The drug is an oral dipeptidyl peptidase 1 (DPP1) inhibitor, targeting neutrophilic inflammation central to NCFB pathogenesis3.

Approved for patients aged 12 years and older, Brinsupri comes in 10mg and 25mg doses and is immediately available in the U.S. via a specialty pharmacy network13.

No prior approved treatments for NCFB existed, making Brinsupri the first-in-class option and a historic milestone in lung disease care3.

Regulatory submissions for Brinsupri (brensocatib) are pending review in Europe and the UK, with Japan filings expected by the end of 202513.

Insmed's chief medical officer highlighted Brinsupri’s potential to become the new standard in NCFB care, given strong clinical data and impact on patients3.

Sources:

1. https://www.morningstar.com/news/dow-jones/202508127215/insmed-gets-fda-ok-of-brinsupri-in-non-cystic-fibrosis-bronchiectasis

3. https://www.worldpharmaceuticals.net/news/insmed-secures-fda-approval-for-brinsupri-to-treat-ncfb/

5. https://www.statnews.com/2025/08/12/insmed-lung-disease-drug-approved/