European regulatory advisors have given their backing to Sanofi and Regeneron’s Dupixent (dupliumab).
The treatment for adults who are candidates for systemic therapy with moderate-to-severe atopic dermatitis received a positive opinion from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP).
It makes it the first targeted biologic to receive a positive opinion from the CHMP for the disease to date, which could put it in a strong position once it receives marketing authorisation.
Dupixent is designed to specifically inhibit overactive signalling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis.
The interleukin-4 (IL-4) and (IL-13) inhibitor will come in a pre-filled syringe for self-administration as a subcutaneous injection every other week and can be used with or without topical corticosteroids.
However, results from the CHRONOS trial showed that the product is even more effective at clearing skin lesions when used in combination with topical corticosteroids.
The CHMP based its opinion on studies from the global LIBERTY atopic dermatitis clinical trials, which incorporated data from nearly 3,000 adult patients with moderate-to-severe atopic dermatitis.
Those studies showed dupliumab avoids steroids and topical prescription therapies of immunosuppressant’s such as cyclosporine and methotrexate, which can cause side effects with chronic use.
In the US, Dupixent is already approved for the treatment of adults priced around $37,000 per patient per year, but had some bad press lately as Amgen sued Sanofi and Regeneron over the drug back in April claiming patient infringement.
In Europe the CHMP’s decisions almost always translate into full approval for the European Union and the final decision on this from the European Commission (EC) is expected in the next three months.