USA – Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval for treatment of oesophagitis (EoE), which could help the drug reach its 10 billion Euros (US$10.7 billion) peak sales target.
The drug has been approved for use as a 300mg weekly treatment for patients aged 12 years and older with EoE.
The Dupixent application was assessed by the FDA under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
Approval came two months ahead of the FDA’s scheduled decision date, underlining the pressing need for more effective treatments for the disease.
Dupixent is also under regulatory review in Europe for EoE and additional filings are planned in other countries before the end of the year.
Following the FDA’s decision, Dupixent has become the first and only available medicine specifically recommended for the treatment of EoE in the US.
The approval is based on a phase 3 randomized, double-blind, placebo-controlled trial that assessed the effectiveness and safety of Dupixent in patients aged 12 years and older with EoE.
The weekly dosing schedule of 300mg showed a significant improvement in the signs and symptoms of EoE, when compared to placebo.
Eosinophilic oesophagitis is a chronic inflammatory disease driven by type 2 inflammation, with around 160,000 patients living with the condition in the US.
It damages the oesophagus, preventing regular function, and for patients living with the condition, swallowing even small amounts of food can be painful.
The chronic condition typically requires repeated treatments such as corticosteroids and diet change to ease the symptoms and Dupixent is the first treatment that targets the underlying cause.
Sanofi and Regeneron are also developing Dupixent for other diseases characterized by type 2 inflammation, including atopic dermatitis in children, some forms of chronic obstructive pulmonary disease (COPD), asthma, and various conditions leading to urticaria (hives).
The partners were disappointed earlier this year when the results of a phase 3 trial in chronic spontaneous urticaria (CSU) failed to show clear efficacy, but they have not given up on the indication.
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