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

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.

Dr.  Joseph Han, a professor at Eastern Virginia Medical School and trial investigator, said patients with the condition have a “miserable” quality of life. He said the drug is a “life changer.”  

“For a long time, over 30 years, we had very little treatment options,” Han said in an interview. “The treatments we had 30 years ago and now were exactly the same until [Dupixent]" won approval.  

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. 

Sanofi's diabetes business has been hurting from U.S. pricing pressure for years, and the drugmaker brought in Olivier Brandicourt in 2015 to help right the ship. He worked to restructure the company and returned the drugmaker to growth, but now he's on the way out. Former Novartis exec Paul Hudson is set to take the role on Sept. 1.

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.  

Novartis' Xolair has also posted positive phase 3 data in chronic rhinosinusitis with nasal polyps, but hasn't yet scored any approvals for the use. GlaxoSmithKline is testing its Nucala in a phase 3 nasal polyps study.