Regeneron, Sanofi Dupixent Single-Dose Pen Approved By FDA

Regeneron Pharmaceuticals Inc. and Sanofi said Friday the U.S. Food and Drug Administration has approved a 300-mg single-dose pre-filled pen for Dupixent dupilumab.
The companies said the pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis, for at-home administration.
The companies said the 300-mg pre-filled pen is expected to be available in the U.S. in the third quarter of 2020. The pre-filled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.
Regeneron and Sanofi are working with the FDA to provide additional data they require to complete their review of the 200-mg pre-filled pen. The pre-filled syringe continues to be available in both 200 mg and 300 mg doses for use in a clinic or at home by self-administration.

https://www.marketscreener.com/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-Sanofi-Dupixent-Single-Dose-Pen-Approved-By-FDA-30797071/