The FDA has approved a new 300mg pre-filled pen for dupilumab to treat several conditions, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. The approval is for patients age 12 and above.
The newly approved pen features a “hidden needle and single-press injection, along with visual and audio feedback to help with administration,” according to a release from the manufacturer. The release also notes the FDA is expected to review a 200mg pre-filled pen as well. Both pens can only be administered only after training by a healthcare professional.
“Chronic type 2 inflammatory diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps can be incredibly complex to manage, leaving patients burdened and apprehensive about their treatment options,” said George D. Yancopolous, MD, PhD, Co-founder, President, and Chief Scientific Officer at Regeneron. “The Dupixent pre-filled pen was specifically designed to provide patients with a new, easy-to-use, convenient option so they can feel more comfortable administering their injections.”
The 300 mg pen is expected to be on the market in the third quarter of 2020.