Dupilumab Under FDA Review for Moderate-to-Severe Asthma

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.

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) injection as add-on maintenance treatment in patients aged ≥12 years with moderate-to-severe asthma. Moderate-to-severe asthma is characterized by overactive or unbalanced levels of immune cells and signaling proteins, including interleukin-4 and interleukin-13.

Dupixent, an interleukin-4 receptor alpha antagonist, was approved in March 2017 for the treatment of moderate-to-severe atopic dermatitis in adults who are not adequately controlled with topical prescription therapies or when they are not advisable.

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The sBLA contains clinical results from 2,888 study patients from the LIBERTY ASTHMA clinical development program. The full findings from the Phase 3 QUEST and VENTURE trials will be submitted for presentation at upcoming medical meetings.

Dupixent is available as a 300mg/2mL strength solution for subcutaneous (SC) injection. The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of October 20, 2018.

For more information call (800) 633-1610 or visit Dupixent.com.