Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage
Insmed Incorporated, a global biopharmaceutical company dedicated to developing new treatments for patients with serious illnesses, announced that the U.S. Food and Drug Administration has approved BRINSUPRI. This medication is taken once a day and is the first FDA-approved treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children aged 12 and older. This approval brings a new treatment option to hundreds of thousands of patients in the U.S. who live with this chronic lung disease, which causes lasting damage and a loss of lung function.

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Doreen Addrizzo-Harris, M.D., FCCP, who is the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and also leads the NYU Langone Health Bronchiectasis and NTM Program, and is an ASPEN investigator, shared, “This FDA approval marks a potential big change in how we treat non-cystic fibrosis bronchiectasis. For the first time, we have a treatment that directly targets neutrophilic inflammation, which is a main cause of bronchiectasis flare-ups. Because of the strong data and the positive results we’ve seen in patients, I believe this could become the new standard in the care of non-cystic fibrosis bronchiectasis.”

Around 500,000 people in the United States have been diagnosed with NCFB, and millions more live with this condition around the world. Unlike other lung diseases that narrow the airways, bronchiectasis causes the airways to permanently widen, making it hard to clear mucus and bacteria. This leads to ongoing inflammation and infections. Patients often experience flare-ups with symptoms like coughing, more mucus, difficulty breathing, and tiredness.

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Elisha Malanga, Executive Director of the Bronchiectasis and NTM Association, added, “Non-cystic fibrosis bronchiectasis has a major impact on the lives of people living with this chronic lung condition, affecting both their physical and emotional health. Many patients face frequent flare-ups, which can interfere with daily life and even lead to more serious disease. The FDA approval of brensocatib is a big and long-awaited development as the first approved treatment for non-cystic fibrosis bronchiectasis. We hope that treatments like this will help people better manage their condition.”

This approval is backed by data from Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In the ASPEN study, patients taking BRINSUPRI at 10 mg or 25 mg doses saw a 21.1% and 19.4% decrease in the number of annual flare-ups compared to those who took a placebo. Both doses also met several secondary goals related to flare-ups, such as delaying the first flare-up and increasing the number of patients who stayed flare-free. Those on the 25 mg dose also had a much slower decline in lung function, measured by forced expiratory volume in one second after using a bronchodilator, after 52 weeks. The most common side effects in the ASPEN trial were upper respiratory infections, headaches, rashes, dry skin, thickened skin, and high blood pressure. Safety outcomes were similar in the WILLOW study, though more people had issues with their gums and teeth.

Martina Flammer, M.D., MBA, Chief Medical Officer at Insmed, said, “The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic moment for patients and for Insmed. By putting patients first, we’ve once again developed a first-in-class medicine for a disease that had no prior treatments. This is a major breakthrough in medicine. We are deeply grateful to the patients, healthcare providers, and advocates who made this possible — this is just the beginning of what we can achieve together for this community.”

BRINSUPRI works by blocking dipeptidyl peptidase 1, which stops the activation of neutrophil serine proteases that cause chronic airway inflammation in NCFB. It is the first therapy approved to target the root cause of this disease’s inflammation. Insmed has also submitted applications for brensocatib approval to the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency. They plan to file for approval in Japan in 2025, with commercial launches expected in 2026, pending regulatory decisions.

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