Sanofi and Regeneron’s Dupixent scores 3rd FDA approval in sinusitis with nasal polyps

By | June 26, 2019


Dupixent won FDA approval Wednesday to treat adult patients with chronic rhinosinusitis with nasal polyps. (Sanofi)

Sanofi and Regeneron’s Dupixent has been charging ahead since its initial approval in moderate-to-severe atopic dermatitis, later picking up a follow-up nod in moderate-to-severe asthma. Wednesday, the drug scored FDA approval for its third use: to treat adults with chronic rhinosinusitis with nasal polyps. 

Dupixent is the first biologic medicine approved for the condition, which obstructs sinuses and nasal passages. The disease leads to difficulty breathing, reduction in sense of smell and taste and facial pressure. It’s also associated with diseases such as asthma.  

In clinical testing, patients who took Dupixent experienced reductions in nasal polyp size and congestion and experienced improvements in their ability to smell. Patients on the med also required less surgery and steroids. Fifty-nine percent of study patients also had asthma, and those patients experienced better lung function, investigators found.

About three-fourths of patients in testing “no longer required either corticosteroids or surgery, the current standards of care,” Regeneron Chief Scientific Officer George Yancopoulos said in a statement. Dupixent is approved for patients who aren’t controlled on the current standard of care.

The nod comes as Dupixent posts big sales growth for Sanofi. Last year, the med pulled in €788 million. It’s an important growth driver, particularly as other areas in Sanofi’s business struggle. Dupixent scored a priority review for the new use back in March. 

Dupixent won its original FDA approval to treat adults with moderate-to-severe atopic dermatitis in March 2017. Last October, the FDA approved a moderate-to-severe asthma indication for the med. And in March, the drug scored an FDA nod in adolescents with moderate-to-severe atopic dermatitis.  


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