Sanofi’s dupilumab joins UK’s early access scheme

Patients with atopic dermatitis are to get early access to Sanofi’s dupilumab before its marketing authorisation in the UK, after the Medicines and Healthcare Products Regulatory Agency issued a positive scientific opinion for the drug through the country’s Early Access to Medicines Scheme (EAMS).

The EAMS was established to secure early availability of innovative new unlicensed medicines to UK patients that have a high degree of unmet clinical need, and has to date largely focused on life-limiting conditions such as cancer. The inclusion of a treatment for atopic dermatitis, a type of chronic eczema, recognises how debilitating this condition can be and how much impact it can have on people’s physical and psychological wellbeing, said Sanofi.

"People dismiss atopic dermatitis as ‘just a skin condition’, but it is much more than that. Atopic dermatitis is a chronic, systemic, inflammatory disease that can have an immense impact on sufferers’ lives," noted Prof Michael Cork, consultant dermatologist, Professor of Dermatology and Head of Sheffield Dermatology Research, University of Sheffield.

"Up until now, doctors have had little to offer even the most severe patients beyond an escalating routine of topical treatments and immunosuppressants. Dupilumab targets an underlying cause of the condition and gives us a new treatment approach for patients with the most clinical need."

The investigational fully human monoclonal antibody is inhibits signalling of IL-4 and IL-13, two key cytokines required for the immune response believed to be a fundamental driver of inflammation associated with atopic dermatitis.

Under EAMS, dupilumab will be available to eligible adult patients who have severe AD that has failed to respond to all currently approved therapies, as well as patients with severe AD who are intolerant of, or ineligible for, all approved treatments.

The drug is currently under review by the European Medicines Agency and the US Food and Drug Administration, with the latter expected to make a decision on the filing by the end of this month.

Strong data

Data from the one-year LIBERTY AD CHRONOS trial, published in the summer last year, showed that adding dupilumab to topical corticosteroids (TCS) significantly improved measures of overall disease severity compared to placebo/TCS.

After 16 weeks (the primary endpoint), 39 percent of patients who received dupilumab 300mg with TCS either weekly or every two weeks achieved clearing or near-clearing of skin lesions, compared to 12 percent of patients receiving placebo/TCS.

Also, sixty-four of patients who received the 300mg weekly dupilumab/TCS regimen, and 69 percent of those treated every two weeks, achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, versus 23 percent in the placebo arm, the results showed.