The US Food and Drug Administration has approved oral brensocatib (Brinsupri) as the first treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and up, pharmaceutical company Insmed has announced.
Medpage Today reports that as a first-in-class reversible dipeptidyl peptidase-1 (DPP-1) inhibitor, brensocatib addresses the underlying inflammatory process of the serious chronic lung disease, which can lead to permanent lung damage and affects roughly half a million people in America.
Sufferers of non-cystic fibrosis bronchiectasis are vulnerable to persistent inflammation and repeated respiratory infections as the progressive disease permanently widens the airways and makes it difficult to clear mucus and bacteria.
The frequent exacerbations patients experience can involve chronic coughing, excessive sputum production, dyspnoea and fatigue, and often require antibiotics and hospitalisation.
Approval was supported primarily by the ASPEN trial. In the phase 3 study, once-daily 10mg or 25mg doses of brensocatib cut the annualised rate of pulmonary exacerbations by 19-21% compared with placebo (P<0.01 for both).
Brensocatib also prolonged the time to first exacerbation and significantly increased the proportion of patients who remained free of exacerbations after a year (48.5% at both doses vs 40.3% with placebo). Furthermore, patients assigned to the higher dose of the DPP-1 inhibitor experienced significantly less lung function decline during the study.
Safety data for approval came from ASPEN and the phase 2 WILLOW trial. Common adverse events occurring at least 2% more frequently with brensocatib than with placebo included upper respiratory tract infection, gingival and periodontal events, headache, rash, dry skin, hyperkeratosis and hypertension, as noted in the labelling.
The drug can be taken with or without food and has no contraindications. The warnings and precautions section notes the potential for dermatologic, gingival, and periodontal adverse reactions. It also advises against use of live attenuated vaccines as it has not been determined whether brensocatib could alter their effectiveness.
During the pandemic, the DPP-1 inhibitor was tested in severe Covid-19 and is also currently being evaluated in a phase II trial of hidradenitis suppurativa.
Medpage Today article – Serious Chronic Lung Disease Gets First FDA-Approved Drug (Open access)
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