Brensocatib (first drug to be approved for BE)

FDA Grants Priority Review to Brensocatib: A Potential Breakthrough for Bronchiectasis Treatment
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On February 6, 2025, the U.S. Food and Drug Administration (FDA) accepted Insmed Incorporated’s New Drug Application (NDA) for brensocatib, granting it Priority Review status.This designation accelerates the regulatory timeline, setting a target PDUFA action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA).

Brensocatib: A First-in-Class DPP1 Inhibitor

Brensocatib is an oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), an enzyme responsible for activating neutrophil serine proteases (NSPs) such as neutrophil elastase. By blocking DPP1, brensocatib aims to reduce NSP activity, which in turn may help decrease inflammation and tissue damage in the lungs.

Addressing an Unmet Need in Bronchiectasis

Non-cystic fibrosis bronchiectasis is a chronic lung disease marked by permanent airway dilation, frequent infections, and excessive inflammation. Despite its rising prevalence—affecting over 500,000 people in the U.S.--there are currently no FDA-approved treatments specifically for this condition.


Brensocatib has the potential to:

• Become the first approved therapy for bronchiectasis
• Represent a new class of treatment targeting neutrophil-driven lung damage
  
  

Promising Results from the ASPEN Study

The NDA submission is backed by data from the Phase 3 ASPEN study—the largest clinical trial ever conducted in patients with bronchiectasis. The study showed that both 10 mg and 25 mg doses of brensocatib significantly reduced the annualized rate of pulmonary exacerbations compared to placebo over a 52-week period.

📄 View Insmed’s ASPEN Study press release.

Brensocatib also demonstrated consistent benefits across diverse patient subgroups, suggesting wide applicability.

Looking Ahead

With FDA Priority Review, brensocatib could soon offer a long-awaited, disease-modifying treatment for patients living with non-cystic fibrosis bronchiectasis. If approved by August 2025, it would mark a major advancement in care, offering hope to those affected by this underrecognized and difficult-to-treat condition.

🧠 Learn more about brensocatib’s mechanism and development on ClinicalTrials.gov.

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