Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition

Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria (CSU), Japan has become the first country to sign off on the blockbuster anti-inflammatory treatment in the indication.

The endorsement from Japan’s Ministry of Health, Labor and Welfare is for patients ages 12 and older as an add-on therapy to antihistamines.

CSU is a severe inflammatory condition that causes sudden hives, deep swelling under the skin and persistent itch. There are approximately 110,000 people in Japan who suffer from uncontrolled moderate-to-severe CSU, Sanofi said in its release.

CSU becomes the sixth global indication for Dupixent, which continued its juggernaut trajectory last year as it raked in $11.6 billion in sales, which was a 33% bump from 2022. The injected monoclonal antibody also has been approved by the FDA for eczema, asthma, chronic rhinosinusitis, eosinophilic esophagitis and prurigo nodularis.

Japan’s nod is based on results of the LIBERTY-CUPID A study, which evaluated 138 CSU patients who were symptomatic despite antihistamine use and had never been treated with Roche and Novartis’ Xolair.

Those who used Dupixent along with antihistamines had a significant reduction in itch severity compared to patients who were on antihistamines alone. The trial met all its primary and secondary endpoints, with the safety profile consistent with Dupixent in its approved dermatological indications.

The FDA’s complete response letter (CSL) requested the companies to bring more compelling efficacy data, citing the failed LIBERTY-CUPID B study. The trial included CSU patients who had not had success with Xolair. Still, Dupixent provided numerical improvements in each of the main evaluation criteria, including itching.

A third LIBERTY-CUPID study is underway and is expected to read out later this year, potentially clearing the path to an FDA nod.

Xolair, which was approved for CSU in 2014 and covers most of the same indications as Dupixent, generated sales of $3.9 billion last year. In 2021, Sanofi said another biologic could thrive on the market because only a small fraction of eligible patients were taking Xolair.

Meanwhile, Sanofi and Regeneron also have high hopes for Dupixent as a treatment for chronic obstructive pulmonary disease (COPD). It would become the first biologic approved for the disease, which affects approximately 300,000 in the U.S. who live with uncontrolled disease and evidence of type 2 inflammation.

The companies submitted their application for approval to the FDA in December and are targeting a launch “as early as mid-2024,” Regeneron CEO Len Schleifer, M.D., Ph.D., said earlier this month.