Regulatory Affairs

Sanofi’s Dupixent to be reviewed by FDA for moderate-to-severe asthma

Published 05 March 2018

Sanofi’s supplemental biologics license application of Dupixent (dupilumab) as an add-on maintenance treatment for certain adults and adolescents having moderate-to-severe asthma has been accepted for review by the US Food and Drug Administration (FDA).

Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.

Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signaling proteins (cytokines) that contribute to Type 2 inflammation in moderate-to-severe asthma.

The application is supported by clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development program.

Detailed results from the Phase 3 QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.

The potential use of Dupixent in asthma is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.

In March 2017, the FDA approved Dupixent in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Dupixent is also approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including the countries of the European Union, Canada, and Japan.

Source: Company Press Release