European Commission gave marketing Authorization for Sanofi’s Dupixent

Sanofi has received marketing authorization from European Commission for Dupixent (Dupilumab). Dupixent is the first targeted biologic in Europe that is known to treat the most common forms of eczema.

Sanofi’s monoclonal antibody is approved for moderate-to-severe atopic dermatitis. This monoclonal antibody work by inhibiting the overactive signaling in two key proteins like IL-4 and IL-13. The key proteins are thought to be the main reason behind the persistent underlying inflammation that is one of the debilitating features of the AD.

The patients generally experience impaired quality of life that includes disrupted sleep and increased anxiety and depression symptoms. The common symptoms associated with this diseases include rashes that often appear most of the body along with itching and skin dryness, cracking and redness, oozing and crusting.

Dupixent (Dupilumab) is available in a pre-filled syringe that can be self-administered via subcutaneous route every fortnight. Dupixent injection is taken following the initial loading dose. A similar drug has also received approval from US authorities in March.

The common treatments that are available include topical corticosteroids that can be used along with Dupixent. These medications are taken to relieve the skin rashes. The treatment is also combined with broad immunosuppressant like ciclosporin.

The clinical trial program “global Liberty AD” includes around 3000 patients. During this trial, Dupilumab is tested either alone or with topical corticosteroids that meets the primary and key secondary endpoints.

In the UK around 1.5 million adults suffer from atopic dermatitis. Sanofi believes that and there could be almost 14 adults per 100,000 with the moderate AD and around 6 adults with severe AD who are eligible for the treatment.

Peter Kuiper, General Manager UK & Ireland, Sanofi Genzyme said, “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.”

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.”


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