Pfizer Secures FDA Approval for Eucrisa in Infants Aged 3 Months and Older with Mild-to-Moderate Atopic Dermatitis

Compiled by Fan Dongdong

Pfizer recently announced that the U.S. FDA has approved a supplemental New Drug Application for Eucrisa (crisaborole, 2% ointment), allowing its use in the treatment of mild-to-moderate atopic dermatitis in pediatric patients aged 3 to 24 months.

Eucrisa is a non-steroidal phosphodiesterase 4 (PDE4) inhibitor. PDE4 mediates the conversion of cyclic adenosine monophosphate (cAMP) to adenosine monophosphate (AMP), thereby reducing intracellular cAMP levels. The drug was originally developed by Anacor, a U.S. biopharmaceutical company. In December 2016, Pfizer acquired Anacor for $5.2 billion in cash, with Eucrisa serving as the core asset of the acquisition.

In the United States, Eucrisa was approved for marketing on December 14, 2016, for the treatment of mild-to-moderate atopic dermatitis in children aged 2 years and older and in adults. In addition to the United States, the drug has also been approved in Canada, Australia, and Israel.

Atopic dermatitis is a specific subtype of eczema, characterized as a severe chronic inflammatory skin disease primarily manifesting as intense pruritus, prominent eczematous changes, and xerosis. In the United States, atopic dermatitis affects nearly 18 million adults and approximately 11% of children. Statistics indicate that globally, around 10% of adults and 20% of children are affected by atopic dermatitis, with 45% of cases onset before six months of age, 60% before one year of age, and 85% before five years of age. Approximately 50% of pediatric patients experience relapses during adolescence and adulthood. Consequently, there is a significant unmet medical need for innovative therapies in this field.

Although atopic dermatitis typically begins in infancy, currently approved treatment options for this patient population are limited. Pfizer stated that this expanded approval makes Eucrisa the first non-steroidal topical prescription medication for pediatric patients aged 3 months and older with mild-to-moderate atopic dermatitis.

This approval is based on data from an open-label Phase IV clinical study designed to evaluate the safety and efficacy of Eucrisa in pediatric patients aged 3 to 24 months with mild-to-moderate atopic dermatitis. In this study, Eucrisa was well tolerated, its efficacy was confirmed, and no new safety concerns were identified.

In China, Eucrisa was included in the "Second Batch of Overseas New Drugs Urgently Needed for Clinical Use" on the grounds that "the disease is a chronic, relapsing inflammatory skin condition with limited current treatment options, and this product provides an effective therapeutic option with a novel mechanism of action for patients who are intolerant to or have failed existing therapies."

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

Reference Source: Pfizer Wins New Pediatric Approval for Atopic Dermatitis Ointment Eucrisa