FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease

The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated’s INSM Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

Brinsupri is the first and only FDA-approved treatment for NCFB, a chronic lung condition characterized by permanently widened and damaged airways (bronchi), leading to persistent mucus production, recurrent infections, and difficulty breathing.

There are approximately 500,000 people in the U.S. diagnosed with NCFB.

The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies.

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In ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, as compared to placebo.

Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.

Patients who received Brinsupri 25 mg experienced a statistically significantly less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52.

The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW.

In parallel, applications for brensocatib 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.

Price Action: INSM stock is up 6.20% at $119.89 at the last check on Tuesday.

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