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Around 500,000 people in the US are estimated to have NCFB, according to Insmed. Credit: HobbitArt via Shutterstock.com. Insmed’s drug Brinsupri (brensocatib) has landed a double regulatory landmark win, becoming both the first marketed dipeptidyl peptidase 1 (DPP1) inhibitor and the first therapy for non-cystic fibrosis bronchiectasis (NCFB) approved by the US Food and Drug Administration (FDA). Brinsupri has been approved to treat adults and children aged 12 years and over with NCFB. The illness is a form of bronchiectasis not caused by cystic fibrosis, instead with airway damage arising from lung infections or inflammatory disorders, among others. Currently, bronchiectasis is treated through airway clearance procedures, antibiotic treatments, and exercise. However, until now, there has been no therapy specifically approved for the condition. Brinsupri, which is orally taken, is available in 10mg and 25mg tablets. GlobalData pharma analyst Vinie Varkey says: “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.” Shares in Nasdaq-listed Insmed closed 7.46% up at market close on 12 August and are currently trading around four times higher compared to a year ago, buoyed by the unveilings of positive clinical data. Brinsupri’s approval was based on results from the Phase III ASPEN (NCT04594369) and Phase II WILLOW (NCT03218917) studies. ASPEN, which enrolled more than 1,700 NCFB patients, demonstrated a significant reduction in the annual rate of exacerbations for patients taking the medication. Exacerbations, also known as flare-ups, are endpoints often used in respiratory disease trials to measure therapy efficacy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Patients who received a 10mg dose of Brinsupri had a 21% reduction compared to those on placebo, while those who received a 25mg dose exhibited a 19% reduction. Varkey adds: “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.” Insmed confirmed that applications for its drug have also been sent to the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with commercial launches anticipated in 2026. Brinsupri is already available in the US by prescription through a comprehensive speciality pharmacy network. The future for Brinsupri is looking bright in its untreaded indication. GlobalData reckons Insemed has a blockbuster on its hands, forecasting sales of $1.7bn by 2033. In an investor presentation, Insmed stated the drug could generate $5bn in peak sales. Around 500,000 people in the US are estimated to have NCFB, according to Insmed. GlobalData forecasts the bronchiectasis market to be worth $3.7bn in 2033 across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, China). GlobalData is the parent company of Pharmaceutical Technology. Brinsupri joins the market alongside Insmed’s only other commercial therapy, Arikayce (amikacin), approved in 2018 to treat Mycobacterium avium complex (MAC) lung disease. Varkey adds: “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.” Her comments highlight an opportunity for DPP-1 inhibitors to expand into other respiratory indications, highlighting further growth avenues for biopharmas. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Insmed appears to have a future blockbuster on its hands, with Mizuho analysts writing Monday that they expect Brinsupri to reach peak sales of $6.6 billion in NCFBE. With a landmark U.S. approval  Tuesday, Insmed is making waves with a new class of drug that’s also the first to be green lit in the chronic lung disease bronchiectasis.The FDA has signed off on Insmed’s brensocatib to treat non-cystic fibrosis bronchiectasis (NCFBE) in adults and kids ages 12 and older. The daily oral drug, approved in both 10 and 25 mg tablets, is already available by prescription through a specialty pharmacy network, Insmed noted in a press release.Prior to Brinsupri's approval, Insmed boasted a single commercial medicine in Arikayce, which was approved in 2018 to treat a narrow group of patients with lung disease caused by the mycobacterium avium complex (MAC) family of bacteria. Now, the New Jersey drugmaker appears to have a future blockbuster on its hands, with Mizuho analysts writing Monday that they expect Brinsupri to reach peak sales of $6.6 billion in NCFBE.Insmed itself believes the drug can generate $5 billion at peak in the indication, according to an investor presentation (PDF) published Tuesday.Aside from bringing the first dedicated treatment for NCFBE to the fore, Brinsupri's FDA approval also marks the introduction of the dipeptidyl peptidase 1 (DPP1) inhibitor class. As a DPP1 inhibitor, Insmed's drug is designed to inhibit an enzyme that activates neutrophil serine proteases (NSPs) in white blood cells. Though NSPs normally help mediate inflammation and destroy pathogens, in certain diseases, they’re activated to excess, leading to inflammation and the destruction of organs.Key opinion leaders (KOLs) who spoke to Mizuho have been “incredibly bullish” about the prospects of Brinsupri, the analysts wrote in their Monday note to clients. The KOLs pointed to the drug’s impressive efficacy and safety data, continuing unmet need in the sizable bronchiectasis market and the general enthusiasm around the drug that’s been expressed by both patients and doctors, according to the analysts.It's estimated that around 500,000 people in the U.S. are diagnosed with NCFB, Insmed noted in its release. The chronic condition causes the walls of the body’s airways to widen and thicken from inflammation and infection. The FDA based its approval of Brinsupri on data from Insmed’s phase 3 ASPEN trial, as well as the company's midstage WILLOW study. The results from the phase 3 trial wowed investors and industry watchers when Insmed unveiled them last May, with the company’s shares now trading up roughly 4 times compared to where they were before the 2024 data drop.In the trial of more than 1,700 NCFBE patients, participants who received a 10 mg dose of Brinsupri charted a 21% reduction in the annual rate of pulmonary exacerbations compared to those on placebo, while patients who received a 25 mg dose of Insmed’s drug experienced a 19% reduction.The drug also won out on multiple key endpoints by helping extend the time before patients’ first pulmonary exacerbation and boosting the odds of patients remaining exacerbation free over an entire year.It wasn’t a perfect showing, however, as the study failed to meet the secondary goal of change in baseline of post-bronchodilator forced expiratory volume in one second at Week 52 for the low dose. Brinsupri also failed to reduce the annualized rate of severe pulmonary exacerbations on either dose.Insmed will price Brinsupri at $88,000 per year before discounts, Mizuho analysts wrote in a new note following a company conference call Tuesday. That sticker price is in line with the range the company had most recently communicated. It will likely be about a month before Insmed starts logging sales from Brinsupri, the analysts added. In turn, sales of the drug in 2025’s third quarter may be “relatively small,” the Mizuho team said in its previous note.With the FDA nod, Insmed’s sales force is expected to “begin engaging with U.S. pulmonologists about Brinsupri immediately,” the company said in its approval slide deck. Insmed isn’t about to be caught flatfooted, as the company has left “no stone unturned to have the strongest launch possible for one of the most anticipated drug launches of the year,” analysts at Leerink Partners wrote in a note to clients last week.The company’s force has been on the ground since last October and has subsequently already engaged with some 27,000 healthcare professionals in the U.S., which the Leerink team noted is “essentially all the pulmonologists in the country.”To further ensure a smooth launch, Insmed has built out a patient support team dubbed inLighten, the analysts pointed out. Wall Street, for its part, has forecasted Brinsupri sales between $40 million and $60 million during the drug’s first year on the market.  Elsewhere, Insmed has submitted additional applications for Brinsupri in the EU and the U.K. The company said last week that it is preparing to file for approval in Japan in the back half of the year as well. Insmed anticipates launching in those territories in 2026 should brensocatib win the requisite approvals in each region. Editor's note: This story was updated with additional details on Insmed's launch preparations.