Sanofi's blockbuster new anti-inflammatory drug, prilumab injection, is approved for new indications in China

On February 24, the official website of the China National Medical Products Administration (NMPA) announced the latest announcement that Sanofi's new anti-inflammatory drug dupilumab injection (dupilumab, English trade name Dupixent) has been approved for new indications.
officially approved
.

According to the priority review announcement of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, the new indications for dupilumab approved in China this time are: for the treatment of external prescription drugs that are poorly controlled or not recommended for use moderate-to-severe atopic dermatitis in children and adults aged 6 years and older and younger than 12 years

Screenshot source: NMPA official website

According to public information, dupilumab is a monoclonal antibody that can inhibit both interleukin-4 (IL-4) and interleukin-13 (IL-13).
A targeted biologic for severe atopic dermatitis, jointly developed by Sanofi and Regeneron
.

Studies have shown that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a major role in diseases such as atopic dermatitis and asthma
.

As a fully human monoclonal antibody, dupilumab can selectively inhibit the key signaling pathways IL-4 and IL-13 through an innovative "dual-target" mechanism of action, block type 2 inflammatory pathways, reduce The pathological response of type 2 inflammation, and the mechanism of treatment of type 2 inflammation-related diseases

In China, dupilumab is one of the new overseas drugs urgently needed in clinical practice.
It has been approved for the treatment of moderate to severe atopic dermatitis in adults in June 2020, and has been included in the 2020 edition of China’s National Medical Insurance Catalogue
.

In May 2021, the product submitted a new indication marketing application in China, and was included in the priority review by CDE.

Screenshot source: CDE official website

The safety and efficacy of dupilumab in combination with corticosteroids in children with severe atopic dermatitis were previously evaluated in a pivotal Phase 3 clinical trial
.

Trials showed that the combination therapy significantly improved disease severity and also relieved pruritus compared to corticosteroids alone

Atopic dermatitis is a severe chronic, relapsing skin disease and the most common form of eczema
.

In severe cases, severe itching results in visible lesions on the skin

It is hoped that the approval of prilumab in China for new indications will bring new treatment options to more patients

References:

[1] On February 24, 2022, the information on the pending receipt of drug approval documents was released.