Sanofi-Aventis Korea has updated the newly confirmed long-term safety data of Dupixent (ingredient: dupilumab) in treating adult patients with atopic dermatitis in Korea.

The recent update was based on the confirmed safety profile up to three years of an open-label extension study conducted on 2,677 patients with moderate to severe atopic dermatitis.

The long-term safety profile observed in the clinical trial was generally consistent with those identified in the 52-week study, and there were no new adverse events or deaths.

In the clinical trial, 99.7 percent of subjects received 300 milligrams of Dupixent weekly. Dupixent is approved in Korea for taking 300 milligrams once every two weeks for adults with moderate to severe atopic dermatitis.

This clinical study result was also reflected in the European Union's summary of product characteristics of Dupixent after the European Medicines Agency's Committee for Medicinal Products for Human Use reviewed it in January.

Unlike non-selective immunosuppressants, Dupixent is a selective immunomodulator, the first to target and regulate the signal transduction of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are major causative agents of type 2 inflammation.

Dupixent is the only biopharmaceutical in Korea that has obtained an indication for treating atopic dermatitis in children older than six.

The clinical data of Dupixent show that IL-4 and IL-13 are key factors in type 2 inflammation, which are known as major causes of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.

The U.S. Food and Drug Administration also granted breakthrough therapy designation in 2016 for treating children between six and 11.

About 60 countries have authorized the use of Dupixent so far, and more than 300,000 patients are being treated with Dupixent.

"The clinical results of Dupixent reflected in the recent update include data confirming the long-term safety profile for three years, the longest period of systemic treatment for atopic dermatitis," said Park Hee-kyung, CEO of Sanofi Genzyme, the business unit of Sanofi Aventis Specialty Care.

Although long-term administration of existing treatments has been limited, the company expects patients to receive appropriate long-term treatment of Dupixent that showed a consistent safety profile, Park added.