FDA approves Dupixent prefilled pen

The Dupixent prefilled pen has been approved by the FDA for all Dupixent indications in patients aged 12 years and older, Regeneron announced in a press release.

The single-dose pen contains 300 mg of Dupixent (dupilumab) and is expected to be available in the United States in the third quarter.

“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,” George D. Yancopoulos, MD, PhD, co-founder, president and chief scientific officer at Regeneron, said in the release. “The Dupixent prefilled pen was specifically designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections.”

The pen features a hidden needle and single-press auto-injection, as well as visual and audio feedback for at-home injections, the release said. Prefilled syringes in both 200 mg and 300 mg doses, for use at home or in the clinic, continue to be available as well.