The European Medicines Agency will review a joint application by Westchester-based Regeneron and Paris-based Sanofi for their products Dupixent (dupilumab) and cemiplimab, the companies said this morning.
They are seeking to have dupilumab as an add-on maintenance treatment in certain adults and adolescents over the age of 12 with inadequately controlled moderate-to-sever asthma.
Dupilumab was discovered using Regeneron”™s proprietary VelocImmune technology that “yields optimized fully human antibodies.” It is being jointly developed by the two drugmakers under a global collaboration agreement.
Dupixent is approved in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin or when those therapies are not advisable. It is also approved in the European Union for use in adults with moderate-to-severe atopic dermatitis.
The European agency will also review the marketing authorization application for cemiplimab, which is used to treat patients with metastatic cutaneous squamous cell carcinoma or patients with such carcinoma who are not candidates for surgery.
Cemiplimab is under clinical development, according to the two companies, and its safety and efficacy has not been fully evaluated by any regulatory authority.
Cutaneous squamous cell carcinoma is one of the most common cancers worldwide, with the number of newly diagnosed cases expected to rise annually.
Advanced CSCC is the deadliest nonmelanoma skin cancer and there are no treatments approved by the European Medicines Agency for advanced CSCC, according to a press release.
