Pharma Focus Asia

Dupixent® (Dupilumab) Approved as The First And Only Targeted Medicine For Eosinophilic Oesophagitis

Monday, January 30, 2023

The European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic oesophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, for those inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease damaging the oesophagus and prevents it from working properly.

With this approval, Dupixent will be the first and only targeted medicine specifically indicated to treat EoE in Europe and the US.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally.

Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In the EU for adolescents and adults with EoE, Dupixent is administered at 300 mg every week. It is available as both a pre-filled pen and pre-filled syringe at the 300 mg dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional.

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