The FDA issued a rare rejection for Sanofi and Regeneron’s Dupixent about a year ago, asking for more efficacy data before it would approve the biologic blockbuster to treat a skin condition marked by chronic hives.
The companies said Wednesday that an additional Phase 3 study succeeded, in what they hope will be sufficient data to clear a path to US approval. Patients with chronic spontaneous urticaria, or CSU, who received Dupixent reported less itch and fewer hives than a placebo group, the trial found.
The drugmakers plan to resubmit for approval by year’s end, setting up Dupixent to be the first targeted therapy for CSU in a decade if approved.
The readout is the latest chapter in an up-and-down journey for Dupixent against the skin condition. Sanofi and Regeneron launched a trio of late-stage studies testing Dupixent in CSU. The first succeeded in 2021, but the second study failed to meet its primary endpoints in 2022. After reviewing those mixed study results for approval, the FDA rejected the drug last October.
This third study, called Study C of the LIBERTY-CUPID trial program, randomized 151 patients to receive Dupixent or a placebo in addition to antihistamines, the standard of care. After 24 weeks, the Dupixent group reported an 8.64-point reduction in itch severity compared to a 6.10-point reduction in the placebo arm. In measuring itch and hive severity, the Dupixent group saw a 15.9-point reduction compared to an 11.2-point drop for the placebo group. Both differences were statistically significant.
Dietmar Berger“With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible,” Dietmar Berger, Sanofi’s chief medical officer and global head of development, said in a statement. “With Dupixent now treating 1 million patients across seven approved indications, these new results underscore there are still many more patients that Dupixent can potentially benefit.”
CSU is a key indication for the growth plans of Dupixent, which recorded over $11 billion in revenue in 2023. The pharmas have estimated about 300,000 people in the US have moderate-to-severe CSU that is inadequately treated with antihistamines. Sanofi and Regeneron said they plan to present the data from Study C at an upcoming medical meeting.
The FDA is also reviewing Dupixent for chronic obstructive pulmonary disease, or COPD, which is seen as another major opportunity for the drug. The agency requested additional efficacy analyses earlier this year, ultimately pushing back its review deadline for COPD from June 27 to Sept. 27.