The U.S. Food and Drug Administration (FDA) has approved Insmed’s brensocatib as the first treatment for non-cystic fibrosis bronchiectasis (NCFBE) in adults and children aged 12 and older. Brensocatib, marketed under the brand name Brinsupri, is an oral, once-daily drug available in 10 mg and 25 mg tablets. The approval marks a significant milestone for Insmed, as brensocatib is expected to generate peak sales of $5 billion annually.
The drug’s approval follows closely watched Phase 3 trials conducted last year, which affirmed its efficacy and safety for patients with NCFBE. NCFBE is a chronic lung condition that causes the walls of the airways to widen and thicken from inflammation and infection. Insmed estimates that around 500,000 people in the U.S. are diagnosed with NCFBE.
The FDA’s approval was based on data from Insmed’s Phase 3 ASPEN trial and the Phase 2 WILLOW study.
Insmed’s first lung treatment
In the ASPEN trial, which included over 1,700 NCFBE patients, brensocatib demonstrated a 21% reduction in the annual rate of pulmonary exacerbations for the 10 mg dose and a 19% reduction for the 25 mg dose compared to placebo.
The drug also extended the time before patients’ first pulmonary exacerbation and improved the odds of remaining exacerbation-free over a year. Insmed will price brensocatib at $88,000 per year before discounts. The company’s sales force is set to engage with U.S. pulmonologists immediately, and sales are expected to begin in about a month.
Wall Street forecasts brensocatib sales between $40 million and $60 million during its first year on the market. Beyond the U.S., Insmed has filed for brensocatib’s approval in Europe and the U.K., with plans to submit applications in Japan later this year. The company aims to launch the drug in these territories in 2026, pending regulatory approvals.