Dupixent (dupilumab) is already a blockbuster drug, generating revenues of around $6 billion in 2021 for French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron (Nasdaq: REGN). But now, with its recent submission to the US Food and Drug Administration for a new indication, eosinophilic esophagitis (EoE), analysts suggest it could add nearly a further $1 billion to sales.
The companies' regulatory filing comes just a couple of weeks after the discontinuation of Takeda’s (TYO: 4502) Eohilia (budesonide oral suspension) after it failed to gain an FDA approval, therefore, if successful, Dupixent will be the first to market for EoE and will offer challenging competition for other biologics trying to find a position in the market, says data and analytics company GlobalData.
The Phase III (NCT03633617) data showed that Dupixent significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo in adolescents and adults ages 12 years and older. Additionally, the firms announced their plan to file for approval in other countries later this year.
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