Sanofi and Regeneron to receive review from EU regulators for Dupixent and Cemiplimab
Sanofi and Regeneron have announced that EU regulators have agreed to review Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
The French pharmaceutical company is seeking approval for Dupixent as an supplementary maintenance treatment in certain adults and adolescents, aged 12 years old and higher, with inadequately controlled moderate-to-severe asthma.
The drug is a human monoclonal antibody specifically designed to inhibit signalling of interleukin-4 (IL-4) and IL-13, two key signalling proteins that contribute to type II inflammation in moderate-to-severe asthma. It is already on the market as a treatment for atopic dermatitis.
The submission for asthma includes data from the Phase III LIBERTY ASTHMA VENTURE study, which showed that by adding Dupixent to standard therapies, there was a significant reduction in the use of maintenance oral corticosteroids (OCS) by 70% on average, compared to 42% with placebo.
The drug was also shown to significantly slash OCS use by 80% on average compared to 43% for placebo in patients with baseline eosinophil counts greater than or equal to 300 cells/microliter.
Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by type II inflammation, including paediatric atopic dermatitis (Phase III), nasal polyps (Phase III) and eosinophilic esophagitis (Phase II).
Cemiplimab is a PD1 antibody under review for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
The filing contains data from the pivotal Phase II EMPOWER-CSCC 1 study, which showed an overall response rate of 46.3% in patients with advanced CSCC, the second deadliest skin cancer after melanoma.
Both medicines are also being reviewed by the FDA