Dupixent Triumphs in Hives Study, Boosting Sanofi and Regeneron

Sanofi and Regeneron are gearing up for another attempt to broaden the application of their highly successful drug, Dupixent, to treat a chronic skin condition that results in hives. The companies had previously faced a setback when the U.S. Food and Drug Administration (FDA) declined their initial application for approval in treating chronic spontaneous urticaria (CSU) last year, citing the need for more efficacy data. However, Sanofi and Regeneron announced on Wednesday that they now possess the required data and intend to resubmit their application to the FDA by the year's end.

The newly collected data comes from the LIBERTY-CUPID Study C, which involved patients suffering from CSU with uncontrolled symptoms despite taking antihistamines. The study showed that patients who added Dupixent to their existing treatment experienced an almost 50% reduction in itch and urticaria activity scores compared to those who received a placebo.

Dupixent, already a top-selling medication with $11.6 billion in revenue last year, was first approved in the U.S. in 2017 for eczema. Over time, its use has expanded to treat various inflammatory conditions, including asthma. Sanofi and Regeneron also revealed positive trial results for another condition, bullous pemphigoid, which causes blisters, and they plan to seek U.S. approval for this indication within the year.

Despite its success, Sanofi and Regeneron have faced challenges in extending Dupixent's market. The FDA postponed a decision on a significant new potential use for the drug in chronic obstructive pulmonary disease (COPD) by three months due to an additional data request, with a decision now expected by September 27.

Furthermore, a small Phase 3 study on severe chronic pruritus of unknown origin did not meet its primary goal, though the companies found encouraging results in other areas and are planning another pivotal study for this indication.

In CSU, Sanofi and Regeneron's initial Phase 3 program yielded mixed outcomes for Dupixent. A previous trial, Study A, was successful in patients on antihistamines who had not been treated with another drug, Xolair. However, Study B, which included patients previously treated with Xolair, did not achieve statistical significance in its primary endpoint. The latest trial, Study C, has provided the companies with the data needed to proceed.

Sanofi and Regeneron plan to rapidly share the results of Study C with the FDA and resubmit their application. Their goal is to enter the U.S. market before competitors like Novartis, which has announced plans to seek global approvals for its CSU medication, remibrutinib, by the end of the year.

Meanwhile, Celldex Therapeutics started two Phase 3 studies of its drug, barzolvolimab, in CSU patients in July, following promising Phase 2 results last year. Although it's challenging to directly compare different clinical studies, analysts at Cantor Fitzgerald find the Dupixent results less impressive compared to the data from Celldex.

As of now, Dupixent is being used by one million patients across seven approved indications. Japan was the first country to approve Dupixent for CSU earlier this year, based on the results from Study A.

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