With a couple of weeks to go before the FDA delivers a verdict on Sanofi’s atopic dermatitis drug Dupixent, the company has new data supporting its efficacy.
The US regulator is due to rule on Dupixent (dupilumab) based on data showing the drug is effective as a monotherapy, but the new phase III data – from the CHRONOS trial – shows that it is even more effective at clearing skin lesions when used in combination with topical corticosteroids.
Dupilumab is an inhibitor of interlukin-4 (IL-4) and IL-13 and according to Sanofi and development partner Regeneron is the first systemic therapy to show efficacy in moderate-to-severe atopic dermatitis, a chronic inflammatory skin disease also known as eczema.
Patients in the trial could not control their atopic dermatitis symptoms with standard medications, including corticosteroids given with or without calcineurin inhibitors such as cyclosporine and methotrexate.
According to results presented over the weekend at the American Academy of Dermatology (AAD) meeting in Orlando, Florida, after a year’s follow-up 36-40% of patients taking dupilumab plus topical steroids given either weekly or every two weeks had clear or almost clear skin, compared to 12.5% of those on topical steroids plus placebo.
Also after a year, the mean percent improvement in overall symptoms from baseline was 78-80% with the active drug, compared to 46% for patients receiving placebo, and there were clinically significant improvements in itching – considered one of the most debilitating symptoms for eczema patients.
Dupilumab is seen as one of the most promising candidates in Sanofi’s near-term pipeline, with analysts at Leerink Swann having previously suggested that dupilumab could reach $2.8bn in sales per year providing it gets a green light in both atopic dermatitis and follow-up indication asthma.
It is estimated there are around 1.6 million people worldwide with atopic dermatitis whose symptoms are uncontrolled on current therapies.
Dupilumab is also under regulatory review in the EU, with the European Medicines Agency (EMA) kicking off its appraisal of the drug last December.