Pfizer Announces FDA Approval of Supplemental New Drug Application for Crisaborole Ointment (2%) in Infants Aged 3 to 24 Months with Mild-to-Moderate Atopic Dermatitis

Meanwhile, the European Commission has recently approved crisaborole ointment (20 mg/g) for the treatment of mild-to-moderate atopic dermatitis (eczema) in patients aged 2 years and older with less than 40% body surface area affected. This is the first non-steroidal topical medication approved for use in European patients in over a decade.
“Family members of patients often spend several hours each day trying to alleviate their children’s eczema symptoms; both infants and caregivers are affected. This is something I observe in my daily practice, and it impacts the entire family,” said Lawrence Eichenfield, MD, Professor of Dermatology and Pediatrics at the University of California San Diego School of Medicine, Vice Chair of Dermatology, and Director of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego. “The approval of nonsteroidal treatment options for this age group offers hope for potential relief for these very young patients.”

Atopic dermatitis (AD) is a chronic skin disease characterized by skin inflammation and impaired skin barrier function. It affects nearly 18 million people in the United States, including approximately 11% of children. Early-onset eczema is most commonly observed during the first two years of life. Among all AD cases, 45% manifest within the first six months after birth, and 60% develop within the first year.

Professor Ma Lin, Director of the Department of Dermatology at Beijing Children’s Hospital, pointed out: “In China, the incidence rate of atopic dermatitis among children aged 1 to 7 years is 12.94%, with higher rates observed in younger children. The primary symptom of atopic dermatitis is ‘pruritus’ (itching), which causes significant discomfort, prevents children from sleeping, and affects their normal growth and development, as well as the quality of life of the entire family. Moreover, it is a relapsing condition; if not effectively controlled over the long term, it may lead to a series of complications, such asAsthma, allergic rhinitis, food protein allergy, etc., making the condition more severe and also bringing a huge economic burden to society.”

The approval of the expanded indication for crisaborole was supported by data from a Phase 4, open-label clinical study. This study aimed to evaluate the safety of crisaborole ointment in pediatric patients aged 3 months to less than 24 months with mild-to-moderate atopic dermatitis (AD), with efficacy assessed as an exploratory endpoint. In this study, 2% crisaborole ointment was well tolerated, demonstrated efficacy in patients with mild-to-moderate AD, and no new safety signals were identified.

“For atopic dermatitis, existing treatment options have many limitations; for example, long-term use of glucocorticoids often leads to side effects,” stated Professor Ma Lin. “Crisaborole ointment is a non-steroidal small-molecule drug that precisely fills a gap in the treatment landscape for atopic dermatitis (eczema), offering a novel therapeutic option for pediatric patients with AD. Currently, this medication has been launched and is in clinical use in multiple countries across Europe and the United States. We look forward to its imminent approval and availability in China, so that Chinese pediatric patients can benefit from this innovative therapy as soon as possible.”

Pfizer Inc. Inflammation andImmunologyGlobal President Richard Blackburn stated, “Although atopic dermatitis typically manifests in infancy, few treatment options are currently approved for this population. We are committed to making meaningful differences in patients’ lives; with the expanded indication, we look forward to helping many children suffering from eczema.”

Note: This product has not yet been approved in China. The information mentioned in this press release should not, under any circumstances, be construed as medical advice or used for promotional purposes.
 
Regarding the CrisADe CARE 1 Study

The sNDA submission is based on data from the Phase 4 CrisADe CARE 1 trial. This four-week, multicenter, open-label, single-arm study evaluated the safety of crisaborole ointment (2%) applied twice daily in 137 pediatric patients aged 3 to <24 months, with efficacy assessed as an exploratory endpoint. All patients had mild-to-moderate atopic dermatitis (AD) involving ≤5% treatable body surface area (%BSA), excluding the scalp. Twenty-one of the 137 subjects were included in a subgroup for pharmacokinetic (PK) assessment, and clinicalDiagnosisfor moderate AD and at least 35% treatable %BSA (excluding the scalp).

About Atopic Dermatitis

Atopic Dermatitis (AD) (Eczema) is a chronic skin disease characterized by skin inflammation and impaired skin barrier function. The lesions of AD are characterized by erythema (redness), induration or papule formation, exudation, and crusting.

In addition to causing physical discomfort, AD also has a significant impact on the emotional and social aspects of personal life9,10. AD may also have negative effects on patients' families, and its impact on children's health-related quality of life may be greater thanDiabetes。

Approximately 50% of children with atopic dermatitis (AD) worldwide experience recurrent symptoms during adolescence and adulthood.

Regarding Crisaborole (2%) Ointment

Crisaborole (2%) ointment is a novel non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor. It has been approved in the United States as EUCRISA® (crisaborole 2% ointment) for the topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and children aged 3 months and older. In Canada, it is approved as EUCRISA® (crisaborole 2% ointment), and in Israel and Australia, it is approved as STAQUIS™ (crisaborole 2% ointment) for the treatment of mild-to-moderate atopic dermatitis (AD) (eczema) in patients aged 2 years and older.