Sanofi, Regeneron to refile Dupixent for skin condition after study success

Sanofi and Regeneron faced a setback roughly a year ago when the FDA denied approval for their biologic drug, Dupixent, aimed at treating chronic spontaneous urticaria (CSU), a skin condition characterized by persistent hives. The regulatory body requested more efficacy data before considering the drug for approval.

The companies announced promising results from an additional Phase 3 clinical trial on Wednesday, which they hope will provide the necessary evidence for FDA approval. This latest trial demonstrated that patients with CSU experienced significant reductions in itchiness and hives when treated with Dupixent compared to those receiving a placebo. 

Sanofi and Regeneron plan to submit these new findings to the FDA by the end of the year, aiming to make Dupixent the first targeted therapy approved for CSU in over a decade. If approved, Dupixent could represent a breakthrough treatment for a condition that has seen limited therapeutic advancements.

Dupixent's path to potential approval for CSU has been turbulent. Sanofi and Regeneron initiated three late-stage trials to assess Dupixent's efficacy in treating CSU. While the first trial yielded positive results in 2021, the second trial did not meet its primary endpoints in 2022. These mixed outcomes led to the FDA's rejection of the drug last October.

The latest trial, known as Study C within the LIBERTY-CUPID trial program, enrolled 151 patients who were randomly assigned to receive either Dupixent or a placebo in addition to standard antihistamine treatment. After 24 weeks, patients treated with Dupixent reported an average reduction in itch severity by 8.64 points, compared to a 6.10-point reduction in the placebo group. In terms of both itch and hive severity, the Dupixent group saw a 15.9-point reduction, whereas the placebo group experienced an 11.2-point decrease. These differences were statistically significant.

Commenting on the results, Dietmar Berger, Sanofi's chief medical officer and global head of development, expressed optimism about the data. "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," he said. He added that Dupixent, which is already approved for seven other indications and treats a million patients, could benefit many more individuals with these new results.

CSU is a critical area for Dupixent's growth trajectory. In 2023, Dupixent generated over $11 billion in revenue. Sanofi and Regeneron estimate that approximately 300,000 people in the United States suffer from moderate-to-severe CSU that is inadequately managed with antihistamines. They intend to present the findings from Study C at an upcoming medical conference.

In addition to CSU, the FDA is also reviewing Dupixent for another major indication: chronic obstructive pulmonary disease (COPD). Earlier this year, the agency requested additional efficacy analyses, which delayed its review deadline for COPD from June 27 to September 27. 

With these new trial results, Sanofi and Regeneron remain hopeful that Dupixent will soon gain FDA approval for treating CSU, offering a new therapeutic option for patients suffering from this challenging skin condition.

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