In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Insmed’s daily oral medication, brensocatib, marketed under the brand name Brinsupri, offering the first targeted treatment for patients with non-cystic fibrosis bronchiectasis (NCFB).
The chronic lung condition, which damages the airways and impairs the body’s ability to clear mucus, affects an estimated 350,000 to 500,000 adults in the United States, according to the American Lung Association.
Widened, thickened, and scarred airways increase susceptibility to recurrent lung infections, often following infections or other lung injuries.
Brinsupri works by inhibiting an enzyme called DPP1, helping to address neutrophilic inflammation — a key factor in bronchiectasis exacerbations. The FDA’s approval follows promising results from a Phase 3 clinical trial last year, highlighting the drug’s potential to significantly improve patient outcomes.
“The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,” said Dr. Martina Flammer, Insmed’s chief medical officer.
Pulmonary specialist Dr. Doreen Addrizzo-Harris of NYU Langone Health emphasized the significance: “For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we’ve seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care.”
Insmed acquired the drug from AstraZeneca for $30 million and is exploring its use in other conditions, including chronic rhinosinusitis. The company plans to launch Brinsupri in the U.S. at an annual list price of $88,000, and has already filed for regulatory approval in Europe and the United Kingdom, with plans to pursue approval in Japan.
Analysts estimate that Brinsupri could become a blockbuster, with peak annual sales projected at $5 billion, STAT News reported.
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