The recent first global approval of dupilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In late March 2017, dupilumab (Dupixent®), co-developed by Regeneron Pharmaceuticals and Sanofi, received its first global approval in the US for the treatment of moderate-to-severe eczema (atopic dermatitis) in adult patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.[1]

Dupilumab is a subcutaneous fully human monoclonal antibody that targets the alpha subunit of the interleukin-4 receptor (IL-4Ra); once bound, it inhibits both IL-4 and IL-13 signalling and subsequently inhibits the release of pro-inflammatory cytokines, chemokines and IgE that are key drivers for the disease. The agent was approved under the FDA’s Priority Review and Breakthrough Therapy programs.[1]

Up to 10% of the adult population in the US has moderate-to-severe eczema[2], and the disease is estimated to affect approximately 3% of the population worldwide.[3]

Dupilumab is dispensed in prefilled syringes for self-administration once every fortnight (after a loading dose).[4] This formulation and dosing regimen provides a treatment option for those patients that have not responded to topical corticosteroids and those for whom the topical treatment is contraindicated.

“To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease,”  said Julie Block, President and Chief Executive Officer, National Eczema Association.[5]

Speaking of the future, Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi explained that  “The approval of DUPIXENT offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally.”[5]

Dupilumab is under review by the EMA, and in the UK, the drug has been granted a positive scientific opinion by the Medicines and Healthcare Products Regulatory Agency via the Early Access to Medicines Scheme in the UK.[6]  Furthermore, the US FDA has granted dupilumab Breakthrough Therapy designation for moderate-to-severe atopic dermatitis in adolescents, and for severe disease in children, in both cases where topical medications are inadequate or inappropriate. Global investigation is ongoing in both adults and paediatrics for atopic dermatitis.

The product label warns against adjustment or cessation of asthma medications without physician consent in patients with comorbid asthma.[4]

For further information related to the first approval of dupilumab please visit Drugs or to learn more about the overall development of dupilumab across all indications visit AdisInsight.

Image credit:  Adiano / Fotolia  

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