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FDA Approves Crisaborole Ointment for Chronic Itchy Skin Condition

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Highlights
  • Atopic Dermatitis is a common skin disease that causes red, scaly bumps on the skin.
  • The Food and Drug Administration has recently approved Pfizer’s Crisaborole ointment for atopic dermatitis.
  • Crisaborole (Eucrisa) is a phosphodiesterase inhibitor drug that is applied topically for treatment.

FDA Approves Crisaborole Ointment for Chronic Itchy Skin Condition

The United States Food and Drug Administration has recently approved the ointment to treat mild or moderate cases of eczema or atopic dermatitis.

Atopic dermatitis is a common disease in children. The chronic itchy skin condition is also referred to as the dermatitis or atopic eczema. This may cause red, scaly bumps on the skin and may occur due to genetic, immune and environmental factors.

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Crisaborole (Eucrisa) is a non-steroidal topical drug for psoriasis and atopic dermatitis. Pfizer has acquired the drug by purchasing Anachor Pharmaceuticals earlier this year. The potential annual peak sales for Crisaborole was found to be about $2 billion.

Regeneron Pharmaceuticals and Sanofi are also waiting for their approval to their injectable drug dupilumab for severe cases of atopic dermatitis.
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Alex Arfaei, BMO Capital Markets analyst said, "Eucrisa will likely have a dosing, safety and price advantage; attractive attributes for dermatologists."

The clinical trials of the drug also reported that many patients who received crisaborole were found to have a clear skin after 28 days of treatment. The placebo controlled trial was conducted on 1522 patients who were between the age group of 2 years to 79 years with atopic dermatitis.

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."

Crisaborole Drug
Crisaborole is a phosphodiesterase inhibitor drug which causes inflammation. It is applied topically twice daily for treating atopic dermatitis.

Common Side Effect of Crisaborole include:
  • Pain on the applied site
  • Allergic reactions
  • Burning or stinging sensation
Reference
  1. Atopic dermatitis - ( https://www.aad.org/public/diseases/eczema/atopic-dermatitis#causes )
  1. FDA approves Eucrisa for eczema - ( http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533371.htm)


Source: Medindia

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