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10/21/2021

FDA approves new indication for Regeneron, Sanofi’s Dupixent

Dupixent is now approved as an add-on maintenance treatment for patients ages 6 to 11 years old with moderate to severe asthma.
Sandra Levy
Senior Editor
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Regeneron and Sanofi have received the Food and Drug Administration’s nod for Dupixent (dupilumab) as an add-on maintenance treatment of patients ages 6 to 11 years old with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.

"Despite available treatments, moderate-to-severe asthma can severely impact children's developing airways, causing sleepless nights, persistent coughing and wheezing, and potentially life-threatening exacerbations that require the use of systemic steroids that can negatively affect growth," George Yancopoulos, president and chief scientific officer at Regeneron said.

[Read more: Regeneron, Sanofi's Dupixent for asthma gets FDA approval]

"This approval means that Dupixent, a first-of-its-kind treatment with a well-established efficacy and safety profile, can now be used by younger children with certain types of moderate-to-severe asthma in the U.S. In our pivotal trial, Dupixent helped children aged 6 to 11 years breathe better, suffer fewer asthma attacks and improve health-related quality of life," Yancopoulos said. "We also continue to study Dupixent in patients with other dermatologic, respiratory and gastrointestinal conditions where type 2 inflammation may play a role."

"This FDA approval brings new hope for children who may be suffering from life-threatening asthma attacks and poor lung function, affecting their ability to breathe, potentially into adulthood," said Naimish Patel, Sanofi head of global development in immunology and inflammation.

[Read more: FDA approves new indication for Regeneron, Sanofi's Dupixent]

Patel continued, "Dupixent has helped to make a difference to the lives of many patients and families across three diseases with underlying type 2 inflammation, with more than 300,000 patients treated globally. We now have the opportunity to offer a safe and effective treatment option to children as young as 6 years of age living with certain types of moderate-to-severe asthma."

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