Insmed (INSM) said Thursday that the US Food and Drug Administration accepted its new drug application for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung condition.
The US regulator granted priority review to the new drug application and has set a target action date of Aug. 12, according to the company.
The application is based on data from the phase 3 Aspen study that showed brensocatib, at both doses tested, significantly reduced lung flare-ups and lowered lung function decline compared to a placebo over one year, Ismed added.
The company said it plans to file regulatory submissions for brensocatib in the European Union, UK and Japan in 2025.
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