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FDA approves Dupixent for atopic dermatitis
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The FDA has approved Dupixent injection to treat adults with moderate-to-severe atopic dermatitis whose disease in not adequately controlled with topical therapies or when those therapies are not advisable.
Dupixent (dupilumab, Regeneron Pharmaceuticals and Sanofi) is the first biologic medicine approved for this indication, according to a press release from Regeneron and Sanofi. It can be used with or without topical corticosteroids.
“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, stated in an FDA press release. “Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease in not controlled by topical therapies.”
Dupilumab an antibody that binds to the interleukin-4 receptor alpha subunit, which causes inflammation. By binding to the protein, dupilumab inhibits inflammatory response that plays a role in the developing atopic dermatitis, according to the FDA.
Safety and efficacy of dupilumab were established in three placebo-controlled clinical trials with 2,119 adults with moderate-to-severe atopic dermatitis not adequately controlled by topical medication. Participants who received dupilumab achieved greater response, defined as clear or almost clear skin, and a reduction in itch after 16 weeks of treatment, according to the FDA release.
Andrew Blauvelt, MD, MBA, presented late-breaking research at the American Academy of Dermatology Annual Meeting on dupilumab with concomitant topical corticosteroids to treat moderate-to-severe atopic dermatitis.
Blauvelt, president of Oregon Medical Research Center, Portland, reported that that long-term treatment with duplimumab plus topical corticosteroids improved atopic dermatitis signs and symptoms, including pruritus, with acceptable safety for up to 1 year when compared with topical corticosteroid treatment alone.
Adverse events reported with dupilumab included serious allergic reaction and eye problems including conjunctivitis and keratitis, with patients advised to consult a health care provider if they experience new or worsening eye symptoms. Common adverse events include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, according to the FDA.
The safety of dupilumab has not been established in the treatment of asthma, and patient who have asthma should not adjust or stop asthma treatment without talking to their physicians, according to the FDA release.
Reference: www.fda.gov; www.regeneron.com; www.sanofi.com
Perspective
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William Philip Werschler, MD, FAAD, FAACS
As a clinical investigator for the dipilumab trials, I'm excited to see this novel breakthrough drug receive FDA approval. Atopic dermatitis/eczema, is a chronic condition of itchy, red, inflamed skin for which there has not been a new systemic therapy in decades. With the approval of dipilumab (Dupixent), clinicians now have a powerful new management tool for moderate to severe atopic eczema.
Equally exciting is the safety profile of dipilumab, which during clinical trials actually significantly reduced the incidence of skin infections. The most common side effect noted in clinical trials was irritation and inflammation of the eyes, along with injection site reactions.
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