FDA Approves Insmed Oral Bronchiectasis Drug

The FDA has approved Insmed Incorporated’s Brinsupri (brensocatib), the first treatment for non-cystic fibrosis bronchiectasis (NCFB).

NCFB causes a permanent widening of the airways, which makes it more difficult to remove mucus and bacteria. This results in chronic inflammation and infection. A progressive disease, NCFB sometimes leads to permanent lung damage and lung function decline. Approximately half a million people in the U.S. have received a diagnosis for NCFB, but it is likely that many more live with the disease.

Brinsupri is a dipeptidyl peptidase 1 (DPP1) inhibitor that targets neutrophilic inflammation by activating neutrophil serine proteases. The FDA has approved 10 mg and 25 mg doses, which are taken as once-daily tablets. In clinical trials, 10 mg Brinsupri reduced the annual rate of exacerbations by 21.1% and 25 mg led to a 19.4% reduction compared to the placebo.

Analysts expect Brinsupri to reach blockbuster status. Insmed has a portfolio of approved and mid- to late-stage investigational medicines, with its most advanced programs in pulmonary and inflammatory conditions.

 

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