European Medicines Agency to review Sanofi-Regeneron’s Dupixent, Cemiplimab
PARIS (Reuters) – The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and Cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday.
They said the EMA had accepted to review an application for Dupixent as an add-on maintenance treatment in certain adults and adolescents with inadequately controlled moderate-to-severe asthma.
They said the EMA had also accepted to review the marketing authorization application (MAA) for Cemiplimab, which is used to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) – a form of skin cancer – or patients with locally advanced CSCC who are not candidates for surgery.
Reporting by Sudip Kar-Gupta; Editing by Subhranshu Sahu