Sanofi's Dupixent Drug Achieves Improvement for Skin Diseases

By Andrea Figueras

Sanofi said its dupixent drug achieved significant improvements for the treatment of two skin diseases.

The French pharmaceutical company said Wednesday that the drug met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe bullous pemphigoid, or BP.

BP is a chronic and relapsing disease characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions, the company said.

In the study, five times more dupixent patients achieved sustained disease remission compared to those on placebo.

The drug was previously granted Orphan Drug Designation by the U.S. Food and Drug Administration, or FDA, for BP, as an investigational medicine intended for the treatment of rare diseases, affecting less than 200,000 people in the country.

The study is part of the Dupilumab development program, which is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. It is expected to support regulatory submissions around the world, starting with the U.S. later this year, Sanofi said.

The company also noted that dupixent met primary and key secondary endpoints in a phase 3 study for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.

Chronic spontaneous urticaria, or CSU, is a chronic skin condition that causes sudden and debilitating hives and persistent itch. More than 300,000 people in the U.S. suffer from this skin condition.

"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 U.S. as soon as possible," Chief Medical Officer and global head of development at Sanofi Dietmar Berger said.

In this study, 30% of dupixent-treated patients reported no urticaria, compared with 18% of those on placebo.

Write to Andrea Figueras at andrea.figueras@wsj.com

(END) Dow Jones Newswires

September 11, 2024 01:53 ET (05:53 GMT)

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