Agency hopes to take action by the end of this year
The United States Food and Drug Administration (FDA) has accepted an application for review that would permit the usage of Dupixent® (dupilumab) as an add-on treatment for moderate-to-severe asthma in adolescents and adults.
The Prescription Drug User Fee Act asserts that the action date for this decision is October 20, 2018.
Dupixent is specially designed to inhibit the signaling of two crucial proteins (IL-4; IL-13) that contribute to Type 2 inflammation in asthma.
Clinical data supports the use of Dupixent via a case study in which almost 3,000 people participated as part of a series of three clinical trials. Detailed results from this Liberty Asthma program, including the Pase 3 QUEST and VENTURE trials, will be available toward the end of 2018.
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.