Sanofi, Regeneron post more positive dupilumab data as PDUFA date for eczema blockbuster-in-waiting nears

Sanofi and Regeneron's dupilumab has a March 29 PDUFA date

Sanofi and Regeneron have taken a deeper dive into phase 3 data on hotly tipped atopic dermatitis drug dupilumab. The fresh results further burnish the credentials of an asset that is up for review at FDA this month.

Dupilumab, which will be sold under the brand name Dupixent if it wins approval, has aced a series of tests over the past year. The latest analysis, which looks at one of three phase 3 studies of the IL-4 and IL-13 inhibiting antibody, continues the winning streak. Dupilumab comfortably beat the placebo against a range of secondary endpoints, regardless of whether the analysis was run after 16 or 52 weeks of treatment.

Having revealed in June that the CHRONOS trial met its primary endpoint of skin lesion clearances after 16 weeks and cleared some key secondary goals, Sanofi and Regeneron have followed up with data on other measurements.

The trial linked both dupilumab regimens—which gave the experimental drug with topical corticosteroids—to statistically significant improvements on the Pruritus Numerical Rating Scale, Patient Oriented Eczema Measure and Dermatology Life Quality Index at 16 and 52 weeks. The proportion of patients whose condition improved against these scales at 16 and 52 weeks were comparable, adding to previously reported data suggesting the effect of Sanofi and Regeneron's drug persists.

"This study provides positive long-term data for Dupixent, which is important given atopic dermatitis is a chronic inflammatory disease,” Andrew Blauvelt, M.D., the principal investigator of the study, said in a statement.

While the CHRONOS trial was primarily designed to track changes to skin lesion clearances and the proportion of patients achieving a 75% reduction on an eczema severity index, the itching, quality of life and patient-oriented results could prove important. Patients with moderate-to-severe atopic dermatitis are poorly served by existing treatment options, and the resulting persistent itching is detrimental to quality of life. Dupilumab appears to help in these regards.

If FDA looks favorably on dupilumab at its PDUFA date later this month—and EMA does likewise later in the year—Sanofi and Regeneron will face the arguably tougher challenge of persuading payors on both sides of the Atlantic to back the drug. The secondary endpoints could come into play then as Sanofi and Regeneron seek to show the value of dupilumab to patients and healthcare systems.

The data put Sanofi and Regeneron at the front of a sizable group of drugmakers that are going after the moderate-to-severe atopic dermatitis market. Leo Pharma, Galderma Pharma and Novartis have all bought a spot in the race over the past year by respectively striking deals with AstraZeneca, Roche’s Chugai Pharmaceutical and Pfizer spinout Ziarco Pharma. But none of the chasing pack has put together a dataset to rival Sanofi and Regeneron’s yet.