The FDA has approved Insmed’s brensocatib, the first treatment for non-cystic fibrosis bronchiectasis, a chronic and progressive lung disease affecting about 500,000 people in the U.S.
The drug was approved for use in adults and children 12 and older and is a once-daily oral medication that targets neutrophilic inflammation, a key driver of the disease, according to an Aug. 12 news release from the drugmaker.
The approval is based on results from phase 2 and phase 3 clinical trials, both of which showed significant reductions in disease exacerbations and improvements in lung function. In the phase 3 trial, the drug reduced the annual rate of exacerbations by over 20% compared to the placebo. The drug is now available in the U.S. for prescription use, the release said.