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.
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.