Therapy Areas: Hereditary Disorders
US FDA grants breakthrough therapy designation for Insmed's Brensocatib
9 June 2020 -

The United States Food and Drug Administration (FDA) has granted United States-based Insmed Incorporated (Nasdaq:INSM) breakthrough therapy designation for its brensocatib (formerly known as INS1007) intended for the treatment of adult patients with non-cystic fibrosis bronchiectasis for reducing exacerbations, it was reported on Monday.

The product is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) presently being developed by the company for the treatment of bronchiectasis and other inflammatory diseases.

Brensocatib has received breakthrough therapy designation based on positive results from the global randomised, double-blind, placebo-controlled Phase two WILLOW study of brensocatib in adults with non-cystic fibrosis bronchiectasis. The company aims to start a phase three program for brensocatib in bronchiectasis in the second half of 2020.

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