EMA to review Sanofi’s Dupixent drug for asthma

The European Medicines Agency (EMA) has agreed to review an application submitted by Sanofi for the use of Dupixent (dupilumab) to treat inadequately controlled moderate-to-severe asthma.

Dupixent is a human monoclonal antibody developed to block interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling associated with type 2 inflammation.

The drug is currently approved in the EU and the US to treat moderate-to-severe atopic dermatitis in adults.

The latest application seeks approval as an add-on maintenance treatment of some asthma patients aged 12 and above.

It includes results from three pivotal trials involving 2,888 subjects under the Liberty Asthma clinical development programme.

"The latest application seeks approval as an add-on maintenance treatment of some asthma patients aged 12 years and above."

Sanofi and Regeneron are also evaluating dupilumab in different development programmes for type 2 inflammatory conditions such as paediatric atopic dermatitis, nasal polyps and eosinophilic esophagitis.

The drug’s supplemental biologics license application (sBLA) is under review by the US Food and Drug Administration (FDA) as an add-on maintenance therapy in select adults and adolescents with moderate-to-severe asthma.

The European regulatory authority has accepted Sanofi’s marketing authorisation application (MAA) for cemiplimab to treat metastatic cutaneous squamous cell carcinoma (CSCC) for review.

Cemiplimab is a human monoclonal antibody being developed by Sanofi and Regeneron to target the programmed cell death protein-1 (PD-1) checkpoint inhibitor.

The MAA is supported by findings from a pivotal, single-arm, open-label Phase II trial and data from two other Phase I expansion cohorts involving advanced metastatic and locally advanced CSCC patients not eligible for surgery.

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