Dupixent reports positive Phase 3 data
On September 15, Sanofi and Regeneron announced Phase 3 data results for Dupixent for the treatment of moderate-to-severe atopic dermatitis in adolescents aged 12 to 17 years. The study data showed a significant improvement in symptoms of atopic dermatitis in the subject population. According to the results, 41.5% of patients who were administered Dupixent every two weeks and 38% who were given Dupixent every four weeks resulted in 75% or more skin improvement. Patients who were administered a placebo only saw an 8% skin improvement. On the following trading day, September 17, SNY stock rose ~0.39% during the day.
In 2016, Dupixent received a breakthrough therapy designation by the FDA for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 to 17 years and for the treatment of severe atopic dermatitis in patients six months to 11 years old. The breakthrough therapy designation enables a faster review and approval process for the drug. The indication is expected to be approved in the first quarter of fiscal 2019, as shown in the time frames in the above diagram.
Current Dupixent markets
Dupixent is currently approved in the United States for the treatment of adults suffering from moderate-to-severe atopic dermatitis who are not advised to use topical prescription therapies or show no significant benefits from them. In the European Union, Dupixent is approved for use in adults with moderate-to-severe atopic dermatitis who are systematic therapy candidates. The drug is also approved in a number of other countries around the world, including Japan and Canada, for use in certain patients suffering from moderate-to-severe atopic dermatitis.