FDA approves Dupixent for chronic rhinosinusitis with nasal polyps
The FDA approved Dupixent for use with other medicines to treat patients with chronic rhinosinusitis with nasal polyps, the agency, Regeneron Pharmaceuticals and Sanofi all announced today.
“Dupixent is the first FDA-approved medicine for adults with chronic rhinosinusitis with nasal polyposis, and the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron Pharmaceuticals, said in a press release.
Sally Seymour, MD, the director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, provided other ways Dupixent (dupilumab, Regeneron Pharmaceuticals, Sanofi) will help patients.
“Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” she said.
Dupilumab, administered by injection, is a fully-human monoclonal antibody that inhibits the signaling of two proteins that affect type 2 inflammation, according to the press releases.
The companies stated that the FDA approval is based on several clinical trials that assessed 300 mg of dupilumab every 2 weeks with standard-of-care mometasone furoate nasal spray vs. placebo injection plus the same standard-of-care nasal spray. These trials showed that patients who received dupilumab saw improvements in nasal congestion/obstruction severity, nasal polyps score reduction, sinus opacification and sense of smell improvement. The companies also reported that users of dupilumab required fewer surgeries, and that dupilumab improved lung function in patients who concurrently had asthma.
According to Regeneron Pharmaceuticals and Sanofi, adverse events in patients who received dupilumab were arthralgia, conjunctivitis, injection site reactions and gastritis. These occurred in 2% or more of the patients.
The companies also indicated that dupilumab has previously been approved by the FDA for moderate-to-severe atopic dermatitis and moderate-to-severe asthma.
Disclosures : Yancopoulous works Regeneron Pharmaceuticals. Seymour works for the FDA.