FDA NewsPerspective

FDA approves Eucrisa for atopic dermatitis in infants

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.

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.

    Perspective

    Lawrence F. Eichenfield

    I'm happy to have a nonsteroidal medication approved for young children with AD. AD is common in young children with variable severity of disease across the spectrum from mild to severe. Historically, we use topical steroids effectively for therapy. However, there are limitations of use with topical steroids in terms of duration of use and quantity of use.

    There's lots of patient and parental concern, especially in infants and young children, regarding the side effects from topical steroids. We have not had a nonsteroidal medication that has been approved [for children] aged younger than 2 years.

    Some patients are intolerant of topical steroids and are admitted into care and it’s a lot of mix and match to topical steroids to nonsteroids. Or for certain regions of the body, side effects can be more severe on delicate skin areas like the face. The nonsteroidal medication is really helpful.

    Disclosure: Eichenfield reports being a consultant and investigator for Pfizer.

    • Lawrence F. Eichenfield, MD
    • Infectious Diseases in Children Editorial Board Member
      Chief, pediatric and adolescent dermatology
      Rady Children’s Hospital
      San Diego