The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for a new 200mg single-dose prefilled pen for Dupixent® (dupilumab) for use in patients 12 years of age and older.

Dupixent, an interleukin-4 receptor alpha antagonist, is indicated for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. Dupixent is currently available as a 300mg/2mL solution in a single-dose prefilled pen and prefilled syringe with needle shield, and as a 200mg/1.14mL solution in a single-dose prefilled syringe with needle shield.

The new 200mg single-dose prefilled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. Patients may self-inject the prefilled pen after training by a health care professional. The 200mg single-dose prefilled pen will be available in August 2021.

References

  1. US Food and Drug Administration, Center for Drug Evaluation and Research. BL 761055/S-016 supplement approval letter. June 14, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s016ltr.pdf
  2. Dupixent [package insert]. Tarrytown, NY and Bridgewater, NJ: Regeneron Pharmaceuticals, Inc. and sanofi-aventis US; 2021.