Following the US FDA approval of Insmed’s Brinsupri for treatment of non-cystic fibrosis bronchiectasis (NCFB):

Vinie Varkey, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“As the first-to-market therapy, Brinsupri (brensocatib) addresses the top unmet need for NCFB: an approved therapy that can reduce exacerbations and slow down the disease progression in adults and children 12 years and older.  Approved doses include the 10mg and 25mg tablets, with no requirement on number of documented pulmonary exacerbations.

“With its approval, Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space. Additionally, Insmed’s Brinsupri marks the first Dipeptidyl Peptidase 1 (DPP-1) inhibitor approved for a respiratory indication, highlighting the potential of this mechanism of action in this therapy area.

“FDA approval is based on results from Phase III ASPEN and Phase II WILLOW studies; the former study evaluated two doses (i.e., 10mg and 25mg) of brensocatib in a patient population that included both adults and adolescents with NCFB. As the first-to-market DPP-1 inhibitor in the respiratory field, Brinsupri is likely to become the standard of care in NCFB treatment. Key opinion leaders interviewed by GlobalData were excited by Brinsupri’s ability to reduce exacerbations and slow the rate of lung function decline. Looking forward, 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.

“For Insmed itself, Brinsupri’s approval will be one that is instrumental in catapulting the company’s profile as a key player within the respiratory space. As an oral DPP-1 inhibitor, the asset targets neutrophilic serine proteases which mediates neutrophilic inflammation, a key factor seen in other diseases such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis. This commonality of underlying disease mechanisms represents an opportunity for DPP-1 inhibitors to expand into other indications, highlighting the wider growth opportunities for pharmaceutical companies in the respiratory field. Brinsupri is currently being evaluated in early-stage clinical trials for other indications including Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) and Hidradenitis Suppurativa (HS).

“GlobalData forecasts the bronchiectasis market to be worth $3.7 billion in 2033 across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, China), growing at a CAGR of 9.8% from 2023 – 2033 as per Bronchiectasis: Opportunity Assessment and Forecast – Update, with US and China collectively 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 $1.7 billion in 2033 across the 8MM, as per GlobalData estimates.”