Regeneron (REGN.US) and Sanofi (SNY.US) have proposed new indications for their blockbuster drugs to be included in the priority review, which will expedite the approval process and make their treatments more accessible to patients.

On March 19, the National Medical Products Administration's Center for Drug Evaluation and Research (CDE) officially announced that Sanofi's (SNY.US) application for the new indication of dupilumab injection had been proposed for priority review. The proposed indication is bullous pemphigoid. On March 11, Regeneron (REGN.US) and Sanofi announced the results of a pivotal 2/3 phase clinical study of dupilumab in adult patients with moderate to severe bullous pemphigoid (BP). The study met all primary and key secondary endpoints. Patients treated with dupilumab achieved a five-fold higher rate of durable remission compared to placebo. Currently, the FDA has accepted Sanofi's application for the approval of dupilumab for the treatment of adult BP and granted it priority review. Bullous pemphigoid (BP) is a chronic and recurrent skin disease characterized by potential type 2 inflammation, typically affecting older populations. It is characterized by intense itching, blisters, skin redness, and painful lesions. Blisters and rashes may cover the entire body, leading to skin bleeding and scabbing, making patients more susceptible to infections and affecting daily life. Dupilumab (dupilumab) is the first FDA-approved anti-IL-4Rα antibody developed by Sanofi and Regeneron. It can block the type 2 inflammation pathway through the innovative "double target" mechanism of IL-4 and IL-13, reducing the pathological response of type 2 inflammation, and treat type 2 inflammation-related diseases from the mechanism. Studies have shown that IL-4 and IL-13 are key drivers of type 2 inflammation and play a crucial role in various inflammatory diseases.