FDA reviews biologics license application for Dupixent for chronic spontaneous urticaria

The FDA has accepted for review the supplemental biologics license application for Dupixent for the treatment of chronic spontaneous urticaria, Regeneron Pharmaceuticals and Sanofi announced in a press release.

The application indicates Dupixent (dupilumab), a fully monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13, for patients aged 12 years and older whose chronic spontaneous urticaria (CSU) is not sufficiently controlled by H1 antihistamine treatment, which is considered the standard of care.

CSU is a type 2 inflammatory skin condition that presents itself through severe hives and angioedema primarily located on the face, hands and feet. In some cases, these symptoms also present in the throat and upper airways. While usually treated with H1 antihistamines, this therapy is only effective in up to 50% of patients, leaving the remainder with limited treatment options, according to the press release.

According to the release, this submission is supported by data from two phase 3 trials, LIBERTY-CUPID studies A and B, in which the former found Dupixent to reduce itch severity by 63% in patients with CSU who do not respond to standard treatment.

The company anticipates an FDA response by Oct. 22, 2023.

Reference:

• Dupixent (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-improved-itch-and-hives. Published July 29, 2021. Accessed March 7, 2023.