With the acceptance of the new drug application and granting priority review, the target action date is August 12, 2025.
The FDA granted priority review to brensocatib, an investigational medication for patients with non-cystic fibrosis bronchiectasis. With the acceptance of the new drug application and granting priority review, the target action date has been set as August 12, 2025. If approved, the drug would become the first and only approved treatment for bronchiectasis and the first in a new class of medications, dipeptidyl peptidase 1, for the treatment of neutrophil-mediated diseases.1
Previously, the drug was granted break through therapy designation by the FDA. | Image Credit: pickup | stock.adobe.com
"Bronchiectasis is a chronic, progressive disease with no approved treatments, leaving hundreds of thousands of people in the US without an effective way to reduce the pulmonary exacerbations that can lead to serious consequences," Martina Flammer, MD, MBA, chief medical officer of Insmed, said in a news release.1 "Brensocatib has the potential to transform the treatment landscape for bronchiectasis, and we were pleased to receive the FDA acceptance of our NDA with priority review even earlier than anticipated.”
The application is based on data from the phase 3 ASPEN (NCT04594369) study, meeting the primary end point for the reduction in annualized rate of pulmonary exacerbations for both dose strengths compared with the placebo over the 52-week treatment period. In the study, investigators included patients who were aged 12 to 85 years with a clinical history of consistent non-cystic fibrosis bronchiectasis, including cough, chronic sputum production, and/or recurrent respiratory infections. Treatment consisted of brensocatib 10 mg, 25 mg, or placebo once daily for 52 weeks. Primary outcomes included rate of adjudicated pulmonary exacerbations, with secondary outcomes including time to first adjudicated pulmonary exacerbation, percentage of patients who are free of pulmonary exacerbations, and number of patients who experience at least 1 treatment emergent adverse event (TEAE).1,2
Trial Name: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
ClinicalTrials.gov ID: NCT04594369
Sponsor: Insmed Incorporated
Completion Date: October 2024
For the primary end point, brensocatib 10 mg reduced annualized pulmonary exacerbations by 21.1% and the 25 mg dosage by 19.4%. Further, remaining exacerbation free was increased by 41.2% and 40%, respectively, and changes in the Quality of Life – Bronchiectasis Respiratory Score at week 52 increased by 2 and 3.8 points, respectively. Patients treated with brensocatib 25 mg also had lower lung function decline measured at week 52 by post-bronchodilator forced expiratory volume over 1 second.1,3
The drug was well-tolerated in the study, with TEAEs occurring in at least 5% of patients treated with either dose and were more frequent than in the placebo, including COVID-19 (15.8%, 20.9%, 15.8%, respectively), nasopharyngitis (7.7%, 6.3%, 7.6%, respectively), cough (7.0%, 6.1%, 6.4%, respectively), and headache (6.7%, 8.5%, and 6.9%, respectively). Severe TEAE occurred in 12.7% and 11.7% for brensocatib 10 mg and brensocatib 25 mg, respectively, compared with 16% for the placebo. TEAEs leading to death occurred in 0.5%, 0.7%, and 1.2%, respectively, and TEAEs leading to discontinuation occurred in 4.3%, 3.8%, and 4.1%, respectively.3
Previously, the drug was granted break through therapy designation by the FDA. Insmed plans to file regulatory submissions for brensocatib in the European Union, the United Kingdom, and Japan in 2025 and expects commercial launches in 2026, pending approval for each regulatory body.1,3
READ MORE: Respiratory Resource Center
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