The US Food and Drug Administration (FDA) approval of Insmed’s Brinsupri marks a significant advancement in the treatment landscape of non-cystic fibrosis bronchiectasis (NCFB) and an incredible milestone for Insmed. As the first-to-market therapy, Brinsupri addresses the top unmet need for an approved therapy that can reduce exacerbations and slow the progression of NCFB in adults and children 12 years and older. The approved doses include the 10mg and 25mg tablets, with no requirement for the number of pulmonary exacerbations. For Insmed itself, Brinsupri’s approval will be instrumental in elevating the company’s profile as a key player in the respiratory space.
The approval was based on results from the Phase III ASPEN study and Phase II WILLOW study; the former study evaluated two doses (10mg and 25mg) of Brinsupri in a patient population that included both adults and adolescents with NCFB. Its primary endpoint was the reduction in annualised rate of pulmonary exacerbations; results demonstrated the rate was lower in the active treatment group compared to placebo [10mg dose: 1.02, 25mg dose: 1.04, placebo: 1.29]. Additionally, it was observed that 48.5% of patients in each active treatment group remained exacerbation-free at week 52 compared to 40.3% in the placebo group. Brinsupri is an oral inhibitor of dipeptidyl peptidase 1 (DPP-1) and targets neutrophilic serine proteases, which mediate neutrophilic inflammation. With its approval, Brinsupri represents the first nonantibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly a shift away from the use of off-label antibiotics in this disease space.
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Brinsupri’s approval also highlights the wider growth opportunities for pharmaceutical companies in the respiratory field. As the first-to-market DPP-1 inhibitor in the respiratory field, Brinsupri is likely to become the standard of care in bronchiectasis treatment. Key opinion leaders interviewed by leading data and analytics company GlobalData were excited by the agent’s ability to reduce exacerbations and slow the rate of lung function decline. In this regard, Brinsupri can anticipate competition from the other DPP-1 inhibitors that are currently in development for bronchiectasis, including Boehringer Ingelheim’s BI-1291583, Haisco Pharmaceutical’s HSK-31858, and Shanghai Fosun Pharmaceutical’s XH-S004. As an oral DPP-1 inhibitor, the asset targets neutrophilic serine proteases, which mediate neutrophilic inflammation, a key factor seen in other diseases such as chronic obstructive pulmonary disease and cystic fibrosis. This commonality of underlying disease mechanisms represents an opportunity for DPP-1 inhibitors to expand into other indications. On that note, it is worth mentioning that Brinsupri is also currently being evaluated in early-stage clinical trials for other indications, including chronic rhinosinusitis without nasal polyps and hidradenitis suppurativa.
As per GlobalData’s estimates, the bronchiectasis market is expected to be worth $3.7bn in 2033 across the 8MM (the US, France, Germany, Italy, Spain, the UK, Japan, and China), growing at a compound annual growth rate of 9.8% from 2023-2033, with the US and China together anticipated to account for 75% of the market in 2033. Brinsupri’s FDA approval is also a pivotal moment of growth in the respiratory field, with the therapy projected to reach sales of $1.7bn in 2033 across the 8MM, as per GlobalData estimates.
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