Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent® (dupilumab) in Moderate-to-Severe Atopic Dermatitis - Seite 3

In the CHRONOS trial, 85 percent of patients who received Dupixent weekly with TCS and 86 percent of patients who received Dupixent every two weeks with TCS completed the 52 week treatment, compared to 67 percent of patients in the placebo group. Patients who received Dupixent with TCS had higher rates of injection site reactions (19 percent Dupixent weekly, 15 percent Dupixent every two weeks and 8 percent TCS alone) and cases of conjunctivitis (19percent Dupixent weekly,14 percent Dupixent every two weeks and 8 percent TCS alone).

The Dupixent Biologics License Application (BLA) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 29, 2017. The FDA granted Dupixent Breakthrough Therapy designation in uncontrolled moderate-to-severe AD in 2014. The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) on December 8, 2016.The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.

Dupixent is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

About Atopic Dermatitis
AD is the most common form of eczema and is characterized by unpredictable flare-ups. It is a chronic inflammatory disease with symptoms often appearing on the skin. Moderate-to-severe AD is characterized by rashes and can include intense, persistent and debilitating itching, skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.

It's estimated approximately 300,000 people in the United States are living with uncontrolled moderate-to-severe AD and despite their current treatment, are most in need of new treatment options. Despite currently available therapies, there still remains an unmet need for treatments that help those adults struggling to manage their moderate-to-severe AD.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).