Express Receives FDA Priority Review Qualification, and Blockbuster IL-4/IL-13 Inhibitors Are Expected to Gain New Indications

▎WuXi AppTec Content Team Editor Today, Regeneron and Sanofi jointly announced that the U.
S.
FDA has granted a supplemental Biologics Application (sBLA) for the blockbuster IL-4/IL-13 inhibitor Dupixent (dupilumab).
) for priority review eligibility for the treatment of patients with eosinophilic esophagitis over 12 years of age
.

If approved, Dupixent would be the first drug approved in the U.
S.
to treat eosinophilic esophagitis, the press release noted
.

Eosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus, preventing it from working properly
.

Sometimes swallowing even a small amount of food or taking a sip of water can cause pain and a blocked esophagus
.

In severe cases, feeding tubes are the only means of maintaining normal energy intake and weight gain
.

People with eosinophilic esophagitis often have poor quality of life and are more likely to experience depression
.

Dupixent is a fully humanized monoclonal antibody that inhibits the signaling of IL-4 and IL-13 proteins
.

Data from the Dupixent clinical trial suggest that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a role in inflammatory diseases such as asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and atopic dermatitis important role
.

Dupixent has been granted Breakthrough Therapy Designation by the FDA for the treatment of eosinophilic esophagitis
.

▲ The mechanism of action of Dupixent (Image source: Sanofi's official website) This sBLA is supported by two phase 3 clinical trials and long-term extended trial data
.

After 24 weeks of Dupixent treatment, symptoms of eosinophilic esophagitis, including the ability to swallow and the number of eosinophils in the esophagus, were significantly improved compared with placebo
.

In terms of safety, the results of this clinical trial are consistent with the safety profile of Dupixent in approved indications
.

The companies plan to file regulatory applications around the world in 2022 to expand the use of Dupixent
.

Reference: [1] FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis.
Retrieved April 4, 2022, from https:// accepts-dupixent-dupilumab-for-priority-review-in-patients-aged-12-years-and-older-with-eosinophilic-esophagitis-301516398.
Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.

This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.

This article is also not a treatment plan recommendation
.

For guidance on treatment options, please visit a regular hospital
.