In a first, the US Food and Drug Administration (FDA) on Tuesday approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema where other topical prescription therapies have failed or were not advisable.
Eczema -- also known as atopic dermatitis -- is a chronic inflammatory skin disease that typically begins in childhood and lasts through adulthood.
It is caused by a combination of genetic, immune and environmental factors, and exhibits extremely itchy red, scaly and crusted bumps on the skin.
"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 is not controlled by topical therapies," Julie Beitz, Director, the Office of Drug Evaluation III, FDA, said in a statement.
"FDA's approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease," Beitz added.
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Antibody dupilumab in Dupixent, administered as an injection under the skin, binds to a inflammation causing protein -- interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra) -- and inhibits the inflammatory response that plays a role in the development of atopic dermatitis (AD).
The FDA has granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc and to Sanofi which is set to market Dupixent in the US.
"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease," said George D. Yancopoulos, Founding Scientist, President, and Chief Scientific Officer at Regeneron.
"The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the US, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally," added Olivier Brandicourt, Chief Executive Officer, Sanofi, in a statement.
To examine the safety and efficacy of Dupixent, scientists also led three placebo-controlled clinical trials with a total of 2,119 adult participants.
While the participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment, some also suffered side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis).
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, the statement said.
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