Brinsupri approved for bronchiectasis

FDA approves Brinsupri, Insmed level branded brensocatib, for bronchiectasis with plans to expand in Europe, the UK and Japan.

Brinsupri wins FDA approval for bronchiectasis

Insmed’s Brinsupri, the daily pill form of brensocatib, won FDA clearance for bronchiectasis, marking the first approved treatment for this chronic lung disease. The approval follows a closely watched Phase 3 trial and sets the stage for international filings in Europe and the UK, with a plan to seek approval in Japan.

The company frames Brinsupri as a potential multibillion-dollar growth driver, citing peak sales projections around $5 billion. That figure underscores the scale of Insmed’s ambitions as it positions Brinsupri to compete with larger biotechs and expand beyond the U.S. market. The international push adds optionality, but it also introduces pricing, reimbursement and regulatory hurdles that vary by region.

This milestone illustrates how niche, targeted therapies are reshaping growth narratives in biotech. Brinsupri’s approval could unlock a broader patient base, yet the path to sustained success will depend on pricing, payer acceptance and timely access across markets. Insmed faces the usual test of translating a Phase 3 win into durable revenue, while navigating competition and potential payer constraints that could temper its upside. The company’s future hinges on codifying a clear global strategy and delivering real-world value to patients who have few options today.

Highlights

Brinsupri’s next chapters will reveal how quickly access and pricing align with demand.