BRIEF—Dupixent pre-filled pen gets FDA nod

The US Food and Drug Administration (FDA) has approved a 300mg single-dose pre-filled pen for Dupixent (dupilumab).

Developed and marketed by French pharma major Sanofi and US biotech Regeneron Pharmaceutical, Dupixent recorded global net sales of $855 million in the first quarter of 2020, a 129% increase from the first quarter of 2019.

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 (CRSwNP), for at-home administration.

This new 300mg pre-filled pen will provide patients with a more convenient option for administering Dupixent and is expected to be available in the USA in the third quarter of 2020.

Regeneron and Sanofi are working with the FDA to provide additional data they require to complete their review of the 200mg pre-filled pen.