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FDA Approves First Bronchiectasis Treatment: brensocatib (Brinsupri)
Last reviewed: 18.08.2025
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For the first time, people with bronchiectasis will have a treatment option. The U.S. Food and Drug Administration (FDA) has approved Insmed's daily pill brensocatib, which will be sold under the brand name Brinsupri. The drug is intended to treat noncystic fibrosis bronchiectasis (NCFB), a chronic condition that damages the lungs and makes it difficult to clear mucus, the company said in a statement.
The approval comes after the drug showed success in one of the most closely watched Phase III clinical trials last year. The company says Brinsupri could be a blockbuster, with peak sales estimated at $5 billion a year, STAT News reports.
“The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,” the company’s chief medical officer, Dr. Martina Flammer, said in a statement.
The American Lung Association estimates that bronchiectasis affects between 350,000 and 500,000 adults in the U.S. It occurs when the airways in the lungs widen, thicken, and become scarred — often after an infection or other injury. This makes it harder to clear mucus, allowing germs and particles to build up and cause repeated lung infections.
Brinsupri works by blocking an enzyme called DPP1. Insmed acquired the drug from AstraZeneca for $30 million and is also testing it for other conditions, such as chronic rhinosinusitis, STAT News reports.
The company plans to sell the drug in the United States at an annual list price of $88,000. It has also filed for approval in Europe and the United Kingdom, and plans to file in Japan.
“For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses the root cause of bronchiectasis flares. Based on the strength of the data and the effect we’ve seen in patients, I believe this could become a new standard of care for non-cystic fibrosis bronchiectasis,” Doreen Addrizzo-Harris, MD, a pulmonologist and critical care specialist and director of the Bronchiectasis Program and NTM at NYU Langone Health in New York City, said in a press release.