By Colin Kellaher
Insmed has won Food and Drug Administration priority review for its application seeking approval of its brensocatib drug candidate for patients with the chronic inflammatory condition non-cystic fibrosis bronchiectasis.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Insmed on Thursday said the FDA set a target action date of Aug. 12, adding that the agency hasn't indicated whether it will convene an advisory committee to discuss the application.
The Bridgewater, N.J., biopharmaceutical company said brensocatib has the potential to become the first and only approved treatment for non-cystic fibrosis bronchiectasis, which causes the lungs' airways to permanently widen and make the lungs more susceptible to infection.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 06, 2025 08:30 ET (13:30 GMT)
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