Insmed Inc., a global biopharmaceutical company, announced this week that the U.S. Food and Drug Administration (FDA) has approved Brinsupri (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. The condition is a progressive disease that can lead to permanent lung damage.
Brinsupri is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline.
Dosages of Brinsupri of 10 mg and 25 mg have been approved for the treatment of NCFB.
There are about 500,000 people in the U.S. diagnosed with NCFB, and it is estimated that millions more are living with this disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. Bronchiectasis manifests itself with frequent exacerbations, or flares, when symptoms worsen, such as coughing, increased mucus, shortness of breath and fatigue.
“This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis,” said Dr. Doreen Addrizzo-Harris, the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis and NTM Program, and SPEN investigator.
“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.”Â
Elisha Malanga, executive director of the Bronchiectasis and NTM Association, said. “The FDA approval of brensocatib represents a significant and long-awaited advancement as the first approved therapy for non-cystic fibrosis bronchiectasis. Our hope is that treatments like this will enable people with bronchiectasis to manage their condition.”
This approval is based on data from the Phase 3 Aspen and Phase 2 Willow studies, which were both published in the New England Journal of Medicine. In Aspen, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in annual rate of exacerbations respectively, as compared with placebo.
Both dosage strengths of Brinsupri prolonged the time to first exacerbation and increased the proportion of patients remaining exacerbation-free over the treatment period. Patients who received Brinsupri 25 mg experienced statistically significant less decline in lung function.
“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, chief medical officer of Insmed. “This is an incredible achievement in medicine. We’re deeply grateful to the patients, providers, and advocates who made this possible – this is just the beginning of what we can accomplish together for this community.”
Applications for the treatment with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. Brinsupri is available in the U.S. by prescription through a comprehensive specialty pharmacy network.
