Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) to treat adults and adolescent patients with eosinophilic oesophagitis (EoE).
The recommendation covers patients aged 12 years and older, weighing at least 40kg, and who are inadequately controlled by, are intolerant to, or are not candidates for conventional medicinal therapy.
Dupixent has already been approved for the treatment of this patient population in the US, with a final decision by the European Commission (EC) expected in the coming months.
The CHMP’s decision was supported by 52-week data from a phase 3 trial in which Dupixent-treated patients experienced improvements in their ability to swallow after just four weeks.
The study also demonstrated histological disease remission, improvements in abnormal endoscopic findings of the oesophagus and cellular improvements after 24 weeks compared to placebo, with outcomes maintained up to a year.
EoE is a chronic inflammatory disease that damages the oesophagus and prevents it from working properly. Symptoms vary between patients, especially in those of different ages, but the condition is mostly characterised by vomiting, stomach or chest pain, difficulty swallowing and food getting stuck in the throat.
Diet adjustment is the standard treatment for EoE, as well as treatments such as proton pump inhibitors, swallowed topical corticosteroids and, in severe cases, a feeding tube to ensure proper caloric intake.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown to be central to the type 2 inflammation underlying EoE.
To date, the treatment has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE or prurigo nodularis in different age populations.
Most recently, Dupixent was approved by the EC to treat adult patients with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
The decision, which followed a recommendation from the CHMP, makes Dupixent the first and only targeted medicine specifically indicated for prurigo nodularis in the EU.
The EC’s decision was based on positive results from two phase 3 trials in which Dupixent demonstrated a significant improvement in itch, skin lesions and health-related quality of life in adults with prurigo nodularis.