FDA approves dupilumab for adolescents with chronic rhinosinusitis with nasal polyps

Key takeaways:

• Dupilumab is the first treatment in the U.S. for CRSwNP for adolescents.
• The approval is supported by data from the SINUS-24 and SINUS-52 trials.

Regeneron Pharmaceuticals Inc. and Sanofi announced the FDA approval of dupilumab for adolescents aged 12 to 17 years with chronic rhinosinusitis with nasal polyps.

Dupilumab (Dupixent), a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, will be used as an add-on maintenance treatment for adolescents with poorly controlled CRSwNP. Dupilumab was previously only approved for patients aged 18 years or older with inadequately controlled CRSwNP.

According to a press release by Sanofi, the approval was supported by positive results from the SINUS-24 and SINUS-52 studies. These studies showed that dupilumab significantly improved nasal congestion and nasal obstruction severity, polyp size and sense of smell. The drug also reduced the need for systemic corticosteroids or surgery when compared with a placebo group.

The approval is also supported by pharmacokinetic data and safety data from adult and adolescent patients with moderate to severe asthma, adults with inadequately controlled CRSwNP and patients aged 12 years and older with moderate to severe asthma.

In the SINUS-24 and SINUS-52 trials, common adverse events included injection site reactions and arthralgia when compared with placebo.

In the Sanofi press release, Brian Foard, executive vice president and head of specialty care at Sanofi, emphasized that this approval marks the first time a biologic is specifically indicated for adolescents with CRSwNP.

“Dupixent is a cornerstone of our leadership in immunology, and this latest approval supports our continued commitment to chasing the miracles of science for patients with unmet medical needs,” Foard said in the release.

The FDA evaluated dupilumab under priority review for this age group. Priority review is reserved for medicines that may have significant improvements in efficacy or safety in treating serious conditions, according to a press release by Regeneron Pharmaceuticals Inc.

According to a press release statement by George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, more than 1 million patients around the world are currently being treated with dupilumab.

“Today’s approval reinforces our continuing commitment to transforming the treatment paradigms for these types of related diseases,” he said.

Reference:

• Dupixent (dupilumab) approved in the U.S. as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP). https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-treatment. Published Sept. 13, 2024. Accessed Sept. 24, 2024.