Pfizer Submits NDA for Crisaborole Ointment in China, a $5.2 Billion Acquisition for Atopic Dermatitis Treatment

On February 10, Pfizer’s marketing application for crisaborole ointment in China was accepted by the Center for Drug Evaluation (CDE).

Crisaborole is a non-steroidal PDE4 inhibitor acquired by Pfizer through its $5.2 billion purchase of Anacor Pharmaceuticals in May 2016. On December 14, 2016, the drug received FDA approval for marketing under the brand name Eucrisa for the treatment of mild-to-moderate atopic dermatitis in pediatric and adult patients. Additionally, it has been approved in Canada, Australia, and Israel. In 2019, the drug generated sales of $138 million.

Atopic dermatitis, commonly known as eczema, is a chronic, relapsing skin disease characterized primarily by intense pruritus, eczematous lesions, and dry skin. It predominantly affects children, with most 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. Previously, this drug was included in the "Second Batch of Clinically Urgent Overseas New Drugs" list.