Crisaborole Gets FDA Approval For Treatment of Atopic Dermatitis

December 22, 2016
Crisaborole Gets FDA Approval For Treatment of Atopic Dermatitis

A recent treatment approved by U.S. FDA has raised hopes for patients suffering from atopic dermatitis (AD). Pfizer Inc. Eucrisa (crisaborole) ointment 2% has turned out to be effective in treating patients suffering from mild to moderate AD, falling in varied age groups, ranging from two year old children to older adults. Nevertheless, a decade has passed since FDA has approved any new prescription treatment for AD.

Crisaborole Fda Approval

Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER), said,

“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis”.

Atopic dermatitis or atopic eczema is a chronic condition which results in skin lesions, characterized by rashes, redness, itchiness etc. The treatment so far implemented to deal with the condition included an application of steroidal creams and moisturizers, intake of topical corticosteroids and several precautionary measures concerning the diet and lifestyle.

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However, the latest Crisaborole Fda Approval has proved to be a significant breakthrough in the field of this eczema classified disease.The decision was confirmed after a successful run trial that affirmed the efficiency of Eucrisa.

The clinical program comprised of two groups with a total of 1,522 patients aged between two years and 79 years with mild to moderate AD. As per the details, 38.5% were examined to be suffering from mild AD, while 61.5% were found to be affected by moderate AD. Patient’s group receiving Eucrisa as part of the 28-day clinical trials, were observed to have either clear or almost clear skin after the regime.

Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine, a clinical trial investigator, said “I’m delighted to have a new option for my patients with mild to moderate atopic dermatitis. The results seen in these pivotal Phase 3 studies show the efficacy and safety of EUCRISA as a steroid-free treatment option for people as young as two living with mild to moderate atopic dermatitis.”

Although, the phosphodiesterase 4, or PDE4 inhibitor, Eucrisa, was found effective against the common symptoms of AD, the mode of its action is still unknown. Moreover, the best part is that the ointment is non-steroidal in nature, unlike other steroid creams available in the market for eczema treatment. For best results, it has been noted that the ointment can be used twice daily.

However, it has been advised that patients that are already hypersensitive to Crisaborole or even any other component of the ointment formulation should refrain themselves from following the treatment. The most common severe effect of the ointment discovered has been pain, burning sensation at the site of application.

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