EU reviews for Sanofi’s Dupixent, cemiplimab

The French drugmaker is seeking approval for Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma.

The drug is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and IL-13, two key signaling 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 adding Dupixent to standard therapies significantly cut the use of maintenance oral corticosteroids (OCS) by 70 percent on average, compared to 42 percent with placebo.

The drug was also shown to significantly slash OCS use by 80 percent on average compared to 43 percent 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 percent in patients with advanced CSCC, the second deadliest skin cancer after melanoma.

Both medicines are also being reviewed by the US Food and Drug Administration.

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