EU first to approve Dupixent for COPD

Chronic obstructive pulmonary disease (COPD) has seen no new therapies brought to market for around 10 years – and now there have been two in the space of a couple of weeks.

The European Commission has become the first regulator worldwide to approve Sanofi and Regeneron’s IL-4 and IL-13 inhibitor Dupixent (dupilumab) as a treatment for the progressive lung disease, shortly after Verona Pharma got the go-ahead from the US FDA for its PDE 3/4 inhibitor Ohtuvayre (ensifentrine).

Dupixent becomes the first-ever targeted therapy for patients with COPD, the first biologic for the disease, and the first new treatment approach in Europe in over a decade. It has been cleared for adults with uncontrolled COPD with raised blood eosinophils, a biomarker for type 2 inflammation seen in around a third of patients, who are already taking standard therapies.

At the moment, the recommended treatment for COPD in Europe is an inhaled corticosteroid (ICS), a long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA), or LABA/LAMA dual therapy if patients cannot use a steroid.

The EU approval has come ahead of a decision in the US, where the FDA delayed the timeline for its verdict on the COPD indication from 27th June to 27th September after asking for additional efficacy data. The drug is also under review for this use in China, Japan, and other countries worldwide.

Sanofi and Regeneron estimate that there are around 220,000 COP patients in the EU who could be eligible for treatment with Dupixent, representing a massive new opportunity for a drug that is already a huge seller across several indications, including atopic dermatitis and severe asthma.

Sales of the antibody reached $12 billion last year and analysts have suggested that COPD could help it to reach $20 billion by the end of the decade, when it will approach the end of its patent life.

COPD is the third leading cause of death worldwide, killing more than three million people in 2019, according to World Health Organization (WHO) estimates, with a devastating impact on patients’ lives as they battle breathlessness and terrifying exacerbations (attacks) that signal the progression of the disease.

In clinical trials, Dupixent reduced the rate of exacerbations or attacks by around a third compared to placebo when added to standard therapies, with improvements in lung function and health-related quality of life scores.

Regeneron’s chief scientific officer, George Yancopolous, said the approval “is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalisation, irreversible health decline, and feelings of hopelessness.”

There is also the prospect of another therapy with a new mechanism of action in the next year or two after Amgen and AstraZeneca’s TSLP-targeting severe asthma therapy Tezspire (tezepelumab) showed signs of efficacy in COPD in a mid-stage trial that also included patients with lower-range eosinophil counts. The companies have suggested it could be suitable for around two-thirds of COPD patients.