The U.S. Food and Drug Administration (FDA) has officially approved Insmed’s brensocatib, which will be sold under the brand name Brinsupri, for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) in both adults and children aged 12 years and older. This therapy is available in two oral dosage strengths-10 mg and 25 mg tablets-to be taken once daily. Brinsupri’s approval is notable not only because it represents the first treatment option ever authorized for this chronic lung condition, but also because it is the first drug in the dipeptidyl peptidase 1 (DPP1) inhibitor class to receive the FDA’s clearance. According to the company, the medication is already accessible through a network of specialty pharmacies for patients with a prescription.
Prior to Brinsupri entering the market, Insmed’s commercial offerings were limited to a single therapy: Arikayce, which the FDA cleared in 2018 to treat certain patients with lung disease caused by the mycobacterium avium complex bacteria. With the addition of Brinsupri to its portfolio, Insmed is expanding into a broader patient population. Analysts from Mizuho have projected that sales of Brinsupri could reach a peak of $6.6 billion for the NCFBE indication, while Insmed’s own forecast places potential peak revenues at approximately $5 billion. The company’s public statements indicate that around 500,000 individuals in the United States are currently diagnosed with NCFBE.
Brinsupri is designed to work by inhibiting the DPP1 enzyme. This enzyme plays a role in activating neutrophil serine proteases (NSPs), which are proteins in white blood cells that help regulate inflammation and destroy harmful pathogens. Under normal circumstances, NSPs are beneficial; however, when activated in excess, they can cause harmful levels of inflammation and damage to tissues and organs.
The approval decision was supported by data from two clinical studies: the Phase III ASPEN trial and the earlier Phase II WILLOW trial. The ASPEN study enrolled over 1,700 patients diagnosed with NCFBE. In the trial, patients who received the 10 mg daily dose of Brinsupri experienced a 21% reduction in the annual rate of pulmonary exacerbations compared to those receiving a placebo.
For patients given the 25 mg daily dose, the reduction was 19% compared to placebo. Brinsupri also succeeded in extending the amount of time before patients experienced their first exacerbation and in increasing the proportion of patients who remained exacerbation-free over the course of a year. However, the trial did not meet its secondary objective of improving lung function for the low-dose group, and the drug did not reduce the annualized rate of severe exacerbations for either dose.
The earlier WILLOW study provided additional evidence by demonstrating that Brinsupri reduced the risk of exacerbations by approximately 40% compared with placebo. These results further supported the FDA’s approval decision.
Insmed has set the annual list price of Brinsupri at $88,000 before any applicable discounts. Analysts at Guggenheim have described this price as being somewhat higher than what was expected. Guggenheim projects that Brinsupri could generate $7.3 billion in sales by 2033. “We believe today’s news sets the stage for a strong launch for Brinsupri,” analysts at Guggenheim stated in their investor note.
The company has indicated that its sales force began preparations as early as October 2024. Since then, representatives have engaged with approximately 27,000 healthcare professionals across the United States, a group that includes nearly all practicing pulmonologists in the country. To provide additional patient support, Insmed has created a dedicated program called inLighten, which is intended to assist patients in initiating and maintaining therapy. Wall Street analysts have estimated that Brinsupri’s first-year revenue could range from $40 million to $60 million, with higher revenues expected in subsequent years as adoption increases.
Beyond the U.S. market, Insmed has already submitted applications for Brinsupri in the European Union and the United Kingdom. The company also plans to submit for approval in Japan during the second half of 2025. If regulatory clearance is granted, Insmed anticipates launching the drug in these markets in 2026.
In addition to its use in NCFBE, Insmed is conducting further clinical research to assess brensocatib’s potential in treating other conditions. These include hidradenitis suppurativa, a chronic inflammatory skin disease, and chronic rhinosinusitis without nasal polyps. Both of these programs are currently in mid-stage clinical development. The company has also announced that it intends to establish a secondary manufacturing source for Brinsupri in order to support future demand.
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