Insmed Gains FDA Approval for First Non-Cystic Fibrosis Bronchiectasis Drug

Insmed has received FDA approval for Brinsupri (brensocatib), the first-ever treatment for non-cystic fibrosis bronchiectasis (NCFBE), a chronic lung disease affecting approximately 500,000 U.S. patients. This once-daily oral medication, available in 10 and 25 mg tablets, targets neutrophilic inflammation by inhibiting the enzyme DPP1, which plays a role in excessive activation of inflammatory proteins that damage lung tissue. The drug's approval follows successful Phase 3 and Phase 2 clinical trials demonstrating reductions in exacerbations and improvements in lung function. Industry analysts and key opinion leaders have expressed strong optimism about Brinsupri's efficacy, safety, and market potential, with peak sales estimates ranging from $5 billion to $6.6 billion. The approval not only represents a major advancement in treating bronchiectasis but also introduces a new drug class, positioning Insmed for significant growth alongside its existing therapies. Brinsupri is already accessible via specialty pharmacies, and Insmed plans to seek regulatory approvals in Europe, the U.K., and Japan.