FDA Approves New Dose for Dupilumab Pre-filled Pen

The FDA has approved a 200 mg single-dose pre-filled pen for dupilumab (Dupixent, Sanofi and Regeneron) for at-home administration in patients 12 years and older across certain indications.

The approved indications include atopic dermatitis and asthma.

The pre-filled pen features a hidden needle and single-press auto-injection, as well as visual and audio feedback to aid in administration. Prior to at-home administration, use of the pre-filled pen requires training by a health care professional.

Recently, the 300 mg dose pre-filled pen was approved by the FDA and is now available.

With the approval of the 200 mg pen, both doses of pre-filled pens have now been approved in the U.S. and European Union.

The new 200 mg pre-filled pen will be available in the U.S. in August 2021.