Insmed gets first FDA approval for bronchiectasis

Insmed has claimed the distinction of becoming the first company to get FDA approval for a treatment for chronic lung disease non-cystic fibrosis bronchiectasis (NCFB).

The US regulator cleared DPP1 inhibitor Brinsupri (brensocatib) for patients aged 12 and older with NCFB, a highly debilitating condition in which the walls of the airways become thickened and damaged as a result of a cycle of inflammation and infections and can become permanently damaged.

Brinsupri becomes an option for hundreds of thousands of people in the US with the disease, which is characterised by repeated exacerbations or attacks, which require treatment with antibiotics and sometimes result in patients being hospitalised.

The drug is thought to work by dampening down inflammation associated with incorrect functioning of neutrophils, a form of white blood cell.

The FDA approval is based mainly on the results of the ASPEN trial, which showed that the drug cut the number of attacks experienced in a year by around 20% compared to placebo, whilst also prolonging the time to a first exacerbation and increasing the chances of patients becoming exacerbation-free over 52 weeks of follow-up.

Insmed – which has said it thinks Brinsupri could achieve global peak sales of $5 billion in the NCFB indication alone – said its salesforce will start engaging with US pulmonologists about the drug "immediately". It is approved in two tablet formulations, 10mg and 25mg, that will both have a list price of around $88,000 per year.

The disease affects 350,000 to 500,000 adults in the US, according to the American Lung Association.

Outside the US, Insmed has filed for approval of brensocatib in the EU and UK, with a marketing application in Japan due in the coming months, and the company expects to launch in all three markets next year.

While Brinsupri will have the market to itself for the time being, there are potential competitors on the horizon, including two other DPP1 inhibitors – Boehringer Ingelheim's verducatib (BI 1291583) and Haisco Pharma/Chiesi's HSK31858 – which are in phase 3 testing for NCFB.

Other drugs in clinical development for bronchiectasis include Armata Pharma's AP-PA02 – a bacteriophage-based therapy for non-CF bronchiectasis caused by chronic Pseudomonas aeruginosa infections – along with Sanofi's anti-IL-33 antibody itepekimab, and Chiesi's human neutrophil elastase inhibitor CHF-633.

Meanwhile, looking to expand the drug's label, Insmed is also running a phase 2b study (BiRCh) in patients with chronic rhinosinusitis without nasal polyps (CRSwNP), with data due before the end of the year, and is enrolling subjects into a second phase 2b trial (CEDAR) in inflammatory skin disorder hidradenitis suppurativa (HS).