The European Commission (EC) has approved Regeneron and Sanofi’s Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU), marking the first approval of a targeted treatment for the condition in more than a decade.

CSU is a chronic inflammatory skin disease characterised by hives and itch. The standard of care treatment for CSU is H1AH, medicines that target H1 receptors on cells. However, many patients find that their symptoms are insufficiently controlled by H1AH, reflecting the unmet need for new treatment options. In the EU, around 270,000 people aged 12 years and older suffer from inadequately-controlled CSU.

“The unpredictable nature of CSU leaves patients guessing when they’ll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging,” Tonya Winders, president & CEO of Global Allergy & Airways Patient Platform, said. 

“Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.”

The drug is a monoclonal antibody that inhibits the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), both of which are key drivers of inflammation. 

It is administered as a subcutaneous injection, and can be administered at home following guidance from a healthcare professional, offering greater patient autonomy. It is not an immunosuppressant.

The approval follows results from two phase 3 trials in the LIBERTY-CUPID programme. Studies A and C found that, when used as an add-on therapy to standard of care antihistamines compared to antihistamines alone, Dupixent significantly reduced urticaria activity compared with placebo at 24 weeks. 

Safety results from the studies were generally consistent with the known safety profile of the drug.

Dupixent is also approved for CSU in certain adults and adolescents in countries including the US and Japan.