Dupilumab, a Biologic Treatment for Eczema, Approved by FDA

Dupilumab (Dupixent) is now approved by the FDA for the treatment of adults with moderate to severe eczema (atopic dermatitis, AD), which affects 7 to 8 million adults in the United States. Dupilumab is a monoclonal antibody that binds to the interleukin-4 receptor alpha subunit (IL-4Ra) that causes inflammation, inhibiting the inflammatory response that is involved in the development of atopic dermatitis. It is now a first-in-class immunotherapy for moderate to severe atopic dermatitis.

Administered as an injection under the skin, dupilumab is intended for patients whose eczema is not adequately controlled by topical therapies, or for those for in whom topical therapies are not advisable. The antibody can be used with or without topical corticosteroids.

Sanofi, which developed dupilumab in collaboration with Regeneron, plans to use social media to spread the word on the new drug and bring atopic dermatitis patients together, working with patient groups and physician thought leaders to better understand eczema and highlight dupilumab as a treatment option. Sanofi has stated that its top goal is that dupilumab gets to the right patient—the patient whose disease is not controlled with a topical steroid. “If your disease could be controlled with a topical steroid, why would you use this drug?” Sanofi Genzyme CEO David Meeker asked. “That’s not the right patient for this drug, and that to me is almost as bad as the person who badly needs it not getting it.” The company also wants to educate payers about atopic dermatitis, so they really understand the disease and the quality-of-life issues faced by patients.

Data from 3 placebo-controlled clinical trials showed dupilumab to be safe and effective. The trials involved 2119 adult with moderate to severe AD that was not adequately controlled by topical medications. Study participants who received dupilumab achieved greater response (clear or almost clear skin) and experienced itch reduction after 16 weeks of treatment, according to the FDA. Results from an ongoing phase 3 study of dupilumab, recently presented annual meeting of the American Academy of Asthma, Allergy, and Immunology (AAAAI) in Atlanta, Georgia, showed that the drug can reduce signs and symptoms of moderate-to-severe AD, and improve skin lesions and pruritus among AD patients without any major safety issues.

Dupilumab can cause side effects such as serious allergic reactions and eye problems including conjunctivitis (pink eye) and inflammation of the cornea. The most common side effects include injection site reactions, cold sores in the mouth or on the lips, and eye and eyelid inflammation, including redness, swelling, and itching.

Classified as a breakthrough therapy, the drug was granted a priority review by the FDA. Sanofi said the drug will have a list price of $37,000 per year. While the price is more expensive than topical medicines and steroids currently used to treat atopic dermatitis, it is less expensive than other injectable antibody drugs for serious skin conditions such as psoriasis. Financial analysts forecast annual sales for dupilumab exceeding $4 billion by 2022.

Sanofi indicated that it has “pivotal data” on Dupixent for an asthma indication that it expects to submit to regulators for that new use in the fourth quarter of 2017. The drug is also in phase 3 trials for nasal polyposis and is being studied in food allergies and eosinophilic esophagitis.