FDA approves expanded use of Dupixent pre-filled pens in young children

The FDA has expanded approval of the single-dose Dupixent pre-filled pen for use in children aged as young as 2 years in approved indications, according to a statement from Regeneron Pharmaceuticals and Sanofi.

The single-dose Dupixent pre-filled pen was previously approved in adults and children aged 12 years and older, according to the statement.

“The Dupixent pre-filled pen is approved for use in the approved indications in patients 2 years of age and older at the 200 mg and 300 mg doses,” a spokesperson from Regeneron and Sanofi told Healio in a prepared statement. “The pre-filled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.”

Self-administration of the Dupixent pre-filled pen require training by a health care professional, and children aged 2 years to younger than 12 years.

Health care professionals are required to train patients and caregivers to use the pre-filled pen, and caregivers should administer Dupixent to patients aged 12 years and younger.