Dupixent (dupilumab) a human monoclonal antibody (mAb) has been approved for an extended indication to treat severe asthma with type 2 inflammation.
The drug inhibits the signaling of two key proteins, interleukin-4 and interleukin-13, that can cause type 2 inflammation in specific types of asthma and other allergic diseases. This inhibition effect is associated with the reduction of type 2 inflammatory biomarkers.
Dupixent was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of eczema (atopic dermatitis), and then for severe asthma with an eosinophilic phenotype in October 2018.
A Sanofi spokesperson told us, “Type 2 inflammation has been shown to contribute to multiple diseases, and following its approval for asthma in the EU, for the first time certain patients with both asthma and atopic dermatitis now have a treatment option for both conditions.”
Severe asthma with type 2 inflammation, according to the companies, is often inadequately controlled by the standard of care treatment and can lead to difficulty breathing, putting patients at risk of asthma attacks that can require hospitalization.
Approval from the European Commission comes after clinical data demonstrated reduced oral corticosteroid use in patients with asthma with type 2 inflammation. The use of oral corticosteroids is common in those who suffer from severe asthma that is inadequately controlled, but according to current asthma guidelines, chronic use has the potential for serious side effects.
Currently, Dupixent is being studied for several diseases caused by type 2 inflammation in both adult and patient populations. These diseases include: chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, chronic obstructive pulmonary disease (COPD), as well as food and environmental allergies.
Antibody Discovery Agreement
Regeneron and Sanofi have collaborated on multiple mAb treatments since 2007. Including the cholesterol lowering Praluent (alirocumab), which was approved in 2015, and Kevzara (sarilumab) for rheumatoid arthritis, which was approved by Health Canada in 2017.
In December 2017, Sanofi and Regeneron ended its Antibody Discovery Agreement. A spokesperson for Sanofi told us that the end of the agreement does not impact the regulatory aspects of the drug and it continues to be developed by both companies under the former agreement.
However, the two companies are still collaborating on immune-oncology discovery and development, and refocused a drug discovery agreement in January 2019 via a $462m deal.