The European Commission has given marketing authorisation for Dupixent (dupilumab), the first targeted biologic in Europe to treat the most common form of eczema.
Sanofi and Regeneron’s human monoclonal antibody is now approved for moderate-to-severe atopic dermatitis (AD). It works by inhibiting overactive signalling in two key proteins, IL-4 and IL-13. These are thought to be behind the persistent underlying inflammation which is a debilitating feature of AD.
Sufferers experience impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms. The disease is characterised by rashes which often cover much of the body, and can include itching and skin dryness, cracking, redness, crusting and oozing.
Dupixent comes in a pre-filled syringe which can be self-administered as a subcutaneous injection every fortnight, following an initial loading dose. US authorities gave similar approval to the drug in March.
The major existing treatments for AD are topical corticosteroids – with which Dupixent can still be used – to relieve skin rashes; or broad immunosuppressants such as ciclosporin.
The global LIBERTY AD clinical trial programme included nearly 3,000 patients and looked at the use of dupilumab either alone or with topical corticosteroids, meeting the primary and key secondary endpoints.
In the UK, approximately 1.5 million adults suffer with AD. Sanofi believes there could be 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment.
“We are already working with the authorities in the UK with the goal of making dupilumab available on the NHS as quickly as possible for those who need it,” said Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme.
Dr Anthony Bewley, Consultant Dermatologist at Whipps Cross University Hospital and the Royal London Hospital, said: “Dupilumab is able to target the root cause of the condition, bringing relief to the aggravating and physical symptoms of atopic dermatitis as well as those difficult symptoms that you can’t see and yet have a negative impact on quality of life, like anxiety, depression and sleep. For dermatologists, this will be a much-welcomed new therapy to offer eligible patients.”