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Insmed Incorporated INSM announced that the FDA has accepted its new drug application (“NDA”) seeking approval of its reversible inhibitor of dipeptidyl peptidase 1 (DPP1), brensocatib, for treating patients with non-cystic fibrosis bronchiectasis.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug. 12, 2025.
If approved, brensocatib will become the first and only approved treatment for bronchiectasis, a chronic lung disease with no approved treatments. It would also become the first DPP1 inhibitor to be approved for the treatment of neutrophil-mediated diseases.
Last month, the company outlined key pipeline goals for 2025. At the time, management stated that upon approval, it expects to launch brensocatib in the United States in the third quarter of 2025.
In the past year, shares of Insmed have skyrocketed 182.7% against the industry’s decline of 6.5%.
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INSM's Brensocatib NDA Based on Data from ASPEN Study
The latest NDA was based on data from the phase III ASPEN study that evaluated two different doses of brensocatib — 10mg and 25mg — against placebo in patients with non-cystic fibrosis bronchiectasis.
The study met its primary endpoint — both doses of brensocatib achieved statistically significant and clinically meaningful reductions in the annualized rate of pulmonary exacerbations compared with placebo.
Treatment with both doses of brensocatib also achieved prespecified exacerbation-related secondary endpoints, including prolonged time to first pulmonary exacerbation and an increase in the odds of remaining exacerbation-free over the treatment period of 52 weeks.
Bronchiectasis is a chronic lung disease in which the bronchi (airways) can become permanently widened. This leads to patients developing respiratory problems such as chronic cough, shortness of breath and repeated respiratory infections and requiring antibiotic therapy and/or hospitalizations.
INSM plans to submit regulatory filings for brensocatib in the United Kingdom, the EU and in Japan later in 2025. Following a potential approval, it expects to launch brensocatib in 2026 in each territory.
Other Studies on INSM's Brensocatib
Besides bronchiectasis, Insmed is also evaluating brensocatib in the phase IIb BiRCh study for treating patients with chronic rhinosinusitis without nasal polyps (CRSsNP). Top-line data readout from the same is expected before the end of 2025.
The company is also evaluating brensocatib in the phase II CEDAR study for the treatment of patients with hidradenitis suppurativa.