The US Food and Drug Administration (FDA) has accepted Sanofi’s supplemental biologics licence application (sBLA) for asthma drug Dupixent (dupilumab) for review.
The application seeks approval for the use of the drug as an add-on maintenance treatment in select adults and adolescents aged 12 years and above suffering from moderate-to-severe asthma.
Characterised by an imbalance or overactivity of immune cells and signalling proteins, moderate-to-severe asthma is accompanied by reduced lung function and severe asthma attacks.
Dupixent, a human monoclonal antibody, is designed to inhibit the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) known to be associated with type 2 inflammation in moderate-to-severe asthma.
It is being co-developed by Sanofi and Regeneron under a global collaboration agreement.
To support the sBLA, the companies have submitted results from three pivotal clinical trials that involved a total of 2,888 adults and adolescents under the LIBERTY ASTHMA clinical development programme.
The FDA approved Dupixent in March 2017 to treat moderate-to-severe atopic dermatitis in adults for whom prescription therapies could not adequately control the disease.
The drug also obtained approval for the treatment of select moderate-to-severe atopic dermatitis in several international markets such as the European Union (EU), Canada and Japan.
Sanofi and Regeneron are currently evaluating Dupixent in various clinical development programmes for other diseases driven by Type 2 inflammation.
Phase III trials are being conducted for paediatric atopic dermatitis and nasal polyps, and a Phase II trial for patients with eosinophilic esophagitis.