Dupilumab approval by FDA US Food and Drug Administration has paved the way for several adults with moderate to severe eczema. Dupixent (dupilumab) injection from the drugmakers, Sanofi – a French pharma industry and Regeneron Pharmaceuticals – a US biotech firm, is a bliss for patients whose eczema symptoms can’t be administered using topical application of creams, ointments or lotions or in case of those for whom such therapies are not recommended. The positive effects of Dupixent are independent of topical corticosteroids usage.
Dupilumab Fda Approval
In a statement, Julie Beitz, Director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, mentioned that the approval granted by FDA for the new drug, Dupilumab, is an assurance of advanced and innovative treatment for the patients with eczema. Dr Beitz added eczema results in persistent skin irritation and uneasiness, hence, it is necessary to assist patients with variety of treatment methods, especially, in case where topical therapies fail to provide significant results.
Atopic Dermatitis or commonly referred to as eczema, is a chronic skin condition that is majorly diagnosed amongst children and the symptoms can last through adulthood. The causes resulting in the onset of the skin ailment, mainly include hereditary, aberrant immune activation, inadequate skin barrier function and environmental factors. Atopic Dermatitis is characterized by red, scaly and itchy skin. Itching and scratching results in swelled and cracked dermis which finally becomes coarse and thick.
In order to test the safety and efficacy of Dupixent, three placebo-controlled clinical trials were carried out. In totality, 2,119 people with moderate to severe type of eczema participated in these trials. The participants included those whose eczema couldn’t be managed using topical remedies. The participants treated with Dupixent reported an alleviation in the sensation of itching after 16 weeks of treatment course and thereby clear or almost clear skin.
Dupixent is injected under the skin. The drug’s main ingredient is the human monoclonal antibody, dupilumab. The deduced mode of action of the antibody demonstrates its binding to a protein, [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra) and also binds to the (IL-13)]. By binding to both proteins, the antibody inhibits their action and shuts down the inflammatory response. The protein is the cause behind inflammation of the skin.
George D. Yancopoulos, Founding Scientist, President, and Chief Scientific Officer at Regeneron, said,
“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. The Dupilumab Fda Approval for eczema 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”.
However, Dupixent may lead to certain side effects like allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). It is highly recommended to consult an eye specialist in case the recipient encounters new symptoms related to the eye like redness, itching, pain or alterations in vision. The most usual side effects were reported as reactions at the injected site, cold sores in the mouth or lip area.
The drug will be launched in the USA market by Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron. The drug is expected to cost $37,000 on an annual basis.