Late-stage trial shows new therapy cuts ventilatory system flare-ups in patients with damaged airways
For the first time, patients with non-cystic fibrosis bronchiectasis have an approved treatment option, as the US Food and Drug Administration (FDA) cleared Insmed Inc.’s oral drug Brinsupri (brensocatib), according to Reuters.
The condition, described in the early 1800s by a French physician, causes permanent airway damage, persistent cough, and excessive mucus production.
As reported by the American Lung Association, it affects 350,000 to 500,000 US adults, with Insmed Chief Executive Officer William Lewis noting the actual number may be higher due to misdiagnosis or overlap with other conditions such as asthma.
Patients often face repeated hospital stays as infections take hold in the mucus-filled airways.
Before this approval, treatment relied on antibiotics, surgery, or mechanical devices such as flutter valves and vibrating vests, typically used to loosen mucus.
Brinsupri works by blocking specific inflammatory enzymes in white blood cells, preventing them from becoming overactive and damaging lung tissue.
Insmed’s submission was based on a late-stage trial involving 1,680 adults and 41 adolescents, which showed the drug significantly reduced respiratory symptoms, including chronic cough, according to Reuters.
The FDA and the company agreed to make both the 10 milligram and 25 milligram doses available, with prescribing physicians selecting the appropriate dose. Lewis said both options will cost $88,000 annually.
Shares of the New Jersey–based company rose 6 percent following the news, as per Reuters, and have gained more than five-fold since May 2024, when late-stage trial results indicated Brinsupri reduced flare-ups such as shortness of breath, Bloomberg reported.
Analysts expect the drug to surpass US$1bn in sales by 2027, with TD Cowen projecting peak US sales of US$3.7bn by 2031.
Lewis said the therapy could drive future profitability for the company, which also markets Arikayce, approved in 2018 for a different chronic lung infection.
Rival therapies in development include AstraZeneca’s benralizumab and Zambon’s inhaled antibiotic therapy CMS I-neb.
