FDA approves Insmed’s Brinsupri, the first DPP1 inhibitor on the market

Insmed’s Brinsupri (brensocatib)was approved by the  FDA as the first treatment for bronchiectasis not caused by cystic fibrosis, as well as being the first DPP1 inhibitor. This marks a major advance in respiratory medicine, with analysts forecasting blockbuster sales.

Zoom in: Bronchiectasis causes persistent coughing, mucus buildup, and airway damage, with no prior targeted drug treatments. Existing options were limited to physical therapy and antibiotics. Brensocatib inhibits DPP1, a protease essential for activating harmful neutrophil enzymes, without impairing infection-fighting ability.

Why it matters: Brinsupri could become a blockbuster with forecasted annual sales up to $6.6 billion by serving a client base of 500,000 Americans living with NCFBE. It's the first drug in a new therapeutic class (DPP1 inhibitors) that may also treat other inflammatory conditions. 

Backstory: Insmed acquired Brinsupri from AstraZeneca in 2016 for $30 million. The drug showed strong efficacy in the phase 3 ASPEN trial, reducing pulmonary exacerbations by up to 21% compared to placebo. It's now available via specialty pharmacies for patients 12 and older.

Big picture: With Brinsupri and Arikayce, Insmed is emerging as a leader in respiratory treatments. Its market cap has surged to $26 billion, surpassing biotech giants like Biogen and Moderna and targeting global expansion to Europe, the U.K., and Japan by 2026.