Insmed wins FDA approval for future blockbuster Brinsupri

Yahoo

2 days ago

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.
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.
"Insmed wins FDA approval for future blockbuster Brinsupri" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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