The ointment had previously been approved for patients ages two and above in 2016.
The U.S. Food and Drug Administration (FDA) greenlit a new pediatric approval for Pfizer’s Eucrisa ointment in the treatment of mild-to-moderate atopic dermatitis, an inflammatory skin disease that impacts a large number of pre-adolescent children.
Pfizer announced late Monday that the FDA approved a supplemental New Drug Application for Eucrisa (crisaborole) ointment, 2%, that allows the use of the medication on children ages three months to 24 months old. The ointment had previously been approved for patients ages two and above in 2016. Pfizer said the approval makes Eucrisa, a topical phosphodiesterase (PDE4) inhibitor, the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as three months of age.
Atopic dermatitis 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 United States. One of the most common forms of atopic dermatitis, early onset atopic dermatitis, typically begins within the first two years of life. Pfizer said that nearly half, about 45%, of all atopic dermatitis cases begins within the first six months of life, and about 60% within the first year.
Richard Blackburn, president of Inflammation & Immunology at Pfizer, said that despite the fact that atopic dermatitis typically begins in infancy, there have been few approved treatment options for this patient population. He said the company is excited about being able to offer Eucrisa to this population and is now looking forward to its efforts to treat the youngest children suffering from eczema. Eucrisa has been approved to treat mild-to-moderate eczema in patients three months of age and older.
The approval for the expanded indication of EUCRISA was supported by data from a Phase IV, 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 atopic dermatitis, with effectiveness as an exploratory endpoint. In this study, all of the patients had mild-to-moderate atopic dermatitis involving at least 5% treatable body surface area. In the study, crisaborole ointment, 2%, was well-tolerated and demonstrated effectiveness in patients with no new safety signals identified, Pfizer said.
The regulatory win follows Pfizer’s decision to postpone its annual Investor’s Day conference due to the ongoing COVID-19 pandemic. The conference was initially set to be held March 31. Pfizer intends to reschedule the event but has not yet set a date. Pfizer will work within the context of appropriate guidance from health authorities to determine a future date, the company said.
