FDA Priority Review for Insmed's brensocatib for bronchiectasis

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis that was submitted by New Jersey, USA-based Insmed (Nasdaq: INSM).

In its Day 60 communication to Insmed, the FDA granted Priority Review to the NDA and set a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA). At present, the FDA has not indicated whether an advisory committee will be convened to discuss the application.

Insmed noted that brensocatib has the potential to become the first and only approved treatment for bronchiectasis and the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for the treatment of neutrophil-mediated diseases.