FDA will decide in June on Dupixent for COPD

FDA will decide in June on Dupixent for COPD

The FDA has started a priority review of Sanofi and Regeneron’s Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), which could become the first new treatment for the widespread and life-threatening disease in over a decade.

IL-4 and IL-13 inhibitor Dupixent (dupilumab) has been filed for people with COPD driven by Th2 inflammation, estimated to account for around a third of cases and associated with high levels of immune cells called eosinophils in the blood.

The US regulator – which has awarded breakthrough status to Dupixent in COPD – is due to decide on the application by 27th June. Meanwhile, the drug has also been submitted for approval in the EU and China and, if approved, will become the first biologic therapy for COPD, according to Sanofi and Regeneron.

COPD is the third leading cause of death worldwide and affects an estimated 12.5 million people in the US, leading to 150,000 deaths, according to 2020 data.

Those numbers are likely underestimated, as COPD is still underdiagnosed and underreported, but the disease nevertheless costs an estimated $30 billion a year to manage in the US. Much of that is driven by exacerbations, the sudden and life-threatening deterioration in lung function that can result in patients being hospitalised.

In two phase 3 trials, NOTUS and BOREAS, Dupixent was able to reduce the rate of exacerbations by around a third compared to placebo when added to standard therapies for COPD that include bronchodilators, inhaled or oral corticosteroids to reduce inflammation in the lungs, and mucolytics to reduce phlegm.

In both trials, Dupixent was also able to achieve rapid and significant improvements in lung function compared to placebo, with the benefit sustained for at least a year.

Analysts at Evercore ISI have previously predicted that Dupixent could make $3.5 billion in sales from COPD alone, driving peak sales of the drug north of $20 billion a year before the end of this decade.

The drug is already a mega-blockbuster, with sales rising by around a third to almost €11 billion (around $12 million) last year from current indications like atopic dermatitis, severe asthma, and chronic rhinosinusitis with nasal polyps.

Sanofi and Regeneron’s COPD pipeline also includes itepekimab, an antibody that binds to and inhibits IL-33 that works against Th1 and Th2 inflammation and is in two phase 3 COPD studies – AERIFY-1 and AERIFY-2 – that are due to report results next year.

COPD is a progressive disease, and patients with more severe forms can see their life expectancy reduced by an average of eight or nine years, according to the Global Allergy & Airways Patient Platform (GAAPP).

23 February, 2024