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Regeneron, Sanofi's Dupixent for asthma gets FDA approval

Regeneron Pharmaceuticals and Sanofi have received the Food and Drug Administration’s blessing for a new indication for Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma age 12 years old and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Dupixent inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers, including fractional exhaled nitric oxide and immunoglobulin E, the company said.

For people with asthma, Dupixent comes in two doses — 200 mg and 300 mg — given every other week at different injection sites after an initial loading dose.

“Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients — those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma,” Regeneron president and chief scientific officer George Yancopoulos said in a statement. “In the asthma clinical trial program, Dupixent reduced severe exacerbations and oral corticosteroid use, improved quality of life, and showed statistically significant and clinically meaningful improvements in lung function. Following the approvals in atopic dermatitis and asthma, and recently announced positive Phase 3 results in chronic rhinosinusitis with nasal polyps, we are committed to advancing our broad development program in additional Type 2 inflammatory diseases.”

"Today’s approval marks a significant development for certain people with moderate-to-severe asthma aged 12 years and older. For patients dependent on oral corticosteroids, Dupixent improved lung function, reduced oral corticosteroid use and reduced exacerbations regardless of baseline eosinophil levels,” Sanofi CEO Olivier Brandicourt said in a statement.
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