- General Dermatology
- Eczema
- Chronic Hand Eczema
- Alopecia
- Aesthetics
- Vitiligo
- COVID-19
- Actinic Keratosis
- Precision Medicine and Biologics
- Rare Disease
- Wound Care
- Rosacea
- Psoriasis
- Psoriatic Arthritis
- Atopic Dermatitis
- Melasma
- NP and PA
- Skin Cancer
- Hidradenitis Suppurativa
- Drug Watch
- Pigmentary Disorders
- Acne
- Pediatric Dermatology
- Practice Management
- Prurigo Nodularis
Article
FDA Approves New Dose for Dupilumab Pre-filled Pen
Author(s):
The FDA has approved a single-dose pre-filled pen for dupilumab (Dupixent, Sanofi and Regeneron) for at-home administration.
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.
