On July 24, Pfizer’s new drug for atopic dermatitis, crisaborole ointment, entered the administrative approval phase for its marketing application in China, with approval expected in the near term.
Atopic Dermatitis, commonly known as eczema, is a chronic, relapsing skin disease characterized primarily by intense pruritus, eczematous lesions, and xerosis. It predominantly affects children, with the majority of cases onset during infancy. Statistics indicate that approximately 10% of adults and 20% of children worldwide are affected by atopic dermatitis. Onset occurs before 6 months of age in 45% of cases, before 1 year of age in 60% of cases, and before 5 years of age in 85% of cases. Approximately 50% of pediatric patients experience recurrence during adolescence and adulthood.
Crisaborole (brand name Eucrisa) is a non-steroidal PDE4 inhibitor developed by Anacor Pharmaceuticals. Pfizer acquired the company for $5.2 billion in May 2016, thereby obtaining the rights to this drug. In December of the same year, crisaborole received FDA approval for marketing, becoming the first prescription medication for atopic dermatitis approved in a decade and the first non-steroidal topical agent that inhibits cutaneous PDE4. In 2019, Eucrisa generated $138 million in sales.
Crisaborole ointment was previously included in China’s “List of the Second Batch of Overseas New Drugs Urgently Needed for Clinical Use.” Pfizer submitted the marketing application for this drug in China in February 2020.
