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Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Pfizer announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema. Eucrisa was previously approved for use in adults and children 2 years of age and older. This supplemental approval makes Eucrisa the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age.

Families often spend hours each day attempting to ease their child’s eczema symptoms, affecting both infants and caregivers. This is a struggle I see in my daily practice, and it can take a toll on the entire family, said Lawrence Eichenfield, M.D., chief of Pediatric and Adolescent Dermatology at Rady Childrens Hospital-San Diego, vice chair of the Department of Dermatology, and a professor of Dermatology and Pediatrics at UC San Diego School of Medicine. The approval of a steroid-free treatment option for this age group offers potential relief for these very young patients.

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects that affects nearly 18 million people and approximately 11% of children in the US. Early onset AD is the most common form of the condition and begins within the first two years of life. A total of 45% of all AD cases begin within the first six months of life, and 60% begin during the first year.

“Despite atopic dermatitis often manifesting during infancy, there are few approved treatment options for this population available today,” said Richard Blackburn, global president, Inflammation & Immunology, Pfizer. “We are committed to making a meaningful difference to patients’ lives, and with this indication extension, we look forward to now helping many of the youngest children suffering with eczema.”

The approval for the expanded indication of EUCRISA was supported by data from a phase 4, open-label, clinical study designed to assess the safety of crisaborole ointment in infants aged 3 months to less than 24 months with mild-to-moderate AD, with effectiveness as an exploratory endpoint. In this study, crisaborole ointment, 2%, was well-tolerated and demonstrated effectiveness in patients with mild-to-moderate AD with no new safety signals identified.

The sNDA submission was based on data from the phase 4 CrisADe CARE 1 trial. The four-week, multicenter, open-label, single-arm study evaluated the safety of crisaborole ointment, 2%, applied twice daily in 137 pediatric patients who were 3 months to less than 24 months of age, with effectiveness as an exploratory endpoint. All patients had mild-to-moderate AD involving at least 5% treatable body surface area (%BSA), excluding the scalp. A cohort of 21 of the 137 subjects was included in a subgroup for pharmacokinetic (PK) assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (redness), induration (hardening)/papulation (formulation of papules), and oozing/crusting.

In addition to causing physical discomfort, AD can also have a significant impact on emotional and social aspects of an individual’s life. AD can also have a negative effect on patients families, and childhood AD may have a greater impact on health-related quality of life than diabetes.

Approximately 50% of pediatric AD patients globally have recurrent symptoms into adolescence and adulthood.

Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor. It is approved in the US as Eucrisa (crisaborole ointment, 2%) for topical treatment of mild-to-moderate AD in adults and pediatric patients 3 months of age and older. Crisaborole is also approved in Canada as Eucrisa (crisaborole ointment, 2%) and Israel and Australia as Staquis (crisaborole ointment, 2%) for mild-to-moderate atopic dermatitis (AD) in patients 2 years of age and older.

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Darshana

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More news about: clinical trials | Published by Darshana | March - 26 - 2020 | 126

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