Yahoo Finance Regeneron (REGN) Dupixent Gets FDA Nod for Asthma in Children
Regeneron REGN announced that the FDA has approved the label expansion of its blockbuster drug Dupixent (dupilumab) as an add-on maintenance therapy to treat moderate to severe asthma with an eosinophilic phenotype or oral corticosteroid-dependent asthma in patients aged 6-11 years.
The FDA approval is based on data from the phase III LIBERTY ASTHMA VOYAGE study, which evaluated the efficacy and safety of Dupixent in combination with standard-of-care asthma therapy (SOC) in children having uncontrolled moderate-to-severe asthma.
Data from the study demonstrated that compared to placebo, the Dupixent-SOC combo substantially reduced asthma attacks by an average of 65%. Participants who were administered the Dupixent-SOC combo also showed improved lung function and asthma control compared to placebo.
Following FDA’s approval, Dupixent is currently the only biologic medicine approved for children with oral corticosteroid-dependent asthma.
Shares of Regeneron have rallied 16.5% so far this year against the industry’s 10.8% decline.
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We remind investors that Dupixent is already approved in the United States and Europe for the above indication in patients aged 12 years or older. The safety profile of Dupixent in patients aged 6-11 years was also consistent with the known safety profile of Dupixent in patients aged 12 years or older.
The company has also filed a regulatory application with the European Union seeking approval for Dupixent to treat children aged 6-11 years with moderate to severe asthma. The same is currently under review.
Apart from asthma, Dupixent is also approved to treat moderate-to-severe atopic dermatitis in patients aged six years and older, and for use with other medicines for maintenance treatment of chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled in the United States, Europe, and some other countries.
We note that dupilumab is a fully human monoclonal antibody developed by Regeneron and Sanofi SNY as part of a global collaboration agreement. Apart from the above indications, both the companies are currently evaluating dupilumab in various mid-stage and late-stage clinical studies across multiple indications including eosinophilic esophagitis, allergic fungal rhinosinusitis as well as peanut allergy.
Dupixent faces stiff competition from Xolair that is developed by Genetech, a member of the Roche Group RHHBY, and Novartis NVO to treat moderate to severe persistent asthma in patients aged 6 years and older.
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