The FDA approved Pfizer’s supplemental new drug application for Eucrisa ointment, 2%, for children as young as age 3 months with mild-to-moderate atopic dermatitis, or AD.
Eucrisa (crisaborole) was previously approved for use in adults and children aged 2 years or older. The supplemental approval makes it the first and only steroid-free, topical prescription medication for patients with AD as young as 3 months of age, Pfizer said.
According to the company, 45% of AD cases begin within the first 6 months of life, and 60% occur within the first year.
The approval for the expanded indication was supported by data from a phase 4, open-label, clinical study that assessed the safety of crisaborole ointment in infants aged 3 months to younger than 24 months with AD, with effectiveness as an exploratory endpoint. In the study the ointment was well tolerated and demonstrated effectiveness in patients with AD with no new safety signals identified, Pfizer said.
“Despite atopic dermatitis often manifesting during infancy, there are a few approved treatment options for this population available today,” Pfizer Global President of Inflammation & Immunology Richard Blackburn said in a statement. “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.” – by Ken Downey Jr.
Disclosure: Blackburn is employed by Pfizer.