FDA Approves New Dupilumab Pre-Filled Pen

Officials with the FDA have expanded the approval for dupilumab (Dupixent; Sanofi and Regeneron) to include a 200 mg single-dose pre-filled pen.¹ The new approval is for patients 12 years of age and older with any of the drug’s previously approved indications, according to a representative of the companies.²

Dupilumab’s approved indications include certain patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and atopic dermatitis.

According to Sanofi, dupilumab is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. The drug is not an immunosuppressant. Data from clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and CRSwNP.³

The new 200 mg-dose product is expected to be available in the United States in August 2021.2 A 300 mg dose is currently available with a prescription.³

Both doses of the dupilumab pre-filled pen feature a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. Training by a health care professional is required for use of these devices at home.²

Serious adverse effects (AEs) of dupilumab may include allergic reactions, eye problems, and inflammation of the blood vessels. Common AEs vary by condition and may include injections site reactions, eye and eyelid inflammation, cold sores in the mouth or on the lips, pain in the throat, high count of a certain white blood cell, insomnia, toothache, gastritis, and joint pain.³

REFERENCES

1. Supplement approval letter. FDA. June 14, 2021. Accessed June 15, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s016ltr.pdf
2. News: FDA approves Dupixent 20 mg pre-filled pen. June 15, 2021. [email]
3. FDA approves new Dupixent (dupilumab) pre-filled pen designed to support more convenient self-administration [news release]. June 19, 2020; Sanofi. Accessed June 15, 2021. https://www.news.sanofi.us/2020-06-19-FDA-approves-new-Dupixent-R-dupilumab-pre-filled-pen-designed-to-support-more-convenient-self-administration