(RTTNews) - Insmed Inc. (INSM), on Thursday, announced that its New Drug Application for Brensocatib, an investigational treatment for patients with non-cystic fibrosis bronchiectasis, has been accepted for priority review by the FDA.
The FDA has set a target action date of August 12, 2025, under the Prescription Drug User Fee Act or PDUFA.
Brensocatib, if approved, would be the first and only available treatment for bronchiectasis, a chronic, progressive lung disease with no approved therapies. It would also be the first in a new class of medicines, dipeptidyl peptidase 1 or DPP1 inhibitors, targeting neutrophil-mediated diseases.
The NDA submission is supported by data from the landmark Phase 3 ASPEN study, which demonstrated that both dosages of brensocatib - 10mg and 25mg - significantly reduced the annualized rate of pulmonary exacerbations compared to placebo. The treatment also showed a reduction in lung function decline.
The FDA had previously granted brensocatib Breakthrough Therapy Designation, expediting its development due to early evidence of substantial improvement over available therapies.
If approved, brensocatib could transform the treatment landscape for bronchiectasis patients, addressing an unmet need in a disease that currently has no approved therapies.
Insmed plans regulatory submissions for brensocatib in Europe, the UK, and Japan in 2025, with commercialization efforts anticipated in 2026, pending approval.
INSM closed Wednesday's (FEB.05 2025) trading at $81.44 up by 0.54%. In premarket trading Thursday the stock is up by 0.68% at $82.00.
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