Extended indication of mAb provides asthma relief

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/catinsyrup)
(Image: Getty/catinsyrup)

Related tags: Asthma, Sanofi, Regeneron, eczema, Monoclonal antibodies, Monoclonal antibody, Fda, Ec

Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.

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.

Related news

Show more

Related products

show more

rAAV Production in BioBLU® Single-Use Vessels

rAAV Production in BioBLU® Single-Use Vessels

Eppendorf for Bioprocess – Solutions that grow with you | 25-Jun-2019 | Application Note

Rising interest in gene therapy-based applications leads to increasing demands in scalable production systems for viral vectors. Find out how Cevec Pharmaceuticals...

Small-Scale Cell Culture Perfusion Process

Small-Scale Cell Culture Perfusion Process

Eppendorf for Bioprocess – Solutions that grow with you | 29-Mar-2019 | Application Note

Perfusion cell culture processes promise advantages for industrial bioprocessing, like saving space, increasing volumetric productivity, achieving more...

Cultivation of 3D Cell Aggregates in Perfusion

Cultivation of 3D Cell Aggregates in Perfusion

Eppendorf for Bioprocess – Solutions that grow with you | 17-Sep-2018 | Application Note

3D cell aggregates are of great interest for applications like disease modeling and manufacturing of stem cell-based products. Read more about the cultivation...

Related suppliers

Follow us


View more