Dupixent® (dupilumab) sBLA Accepted for FDA Review for
3 days ago · FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron ...
Dupixent® (dupilumab) sBLA Accepted for FDA Review for the …
3 days ago · Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity. More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...
Regeneron/Sanofi's Dupixent Approval Signals Major Treatment ...
4 days ago · The introduction of Dupixent changes the treatment landscape by specifically targeting type 2 inflammation pathways (IL-4 and IL-13), which play a role in COPD patients with elevated eosinophils ...
Press Release: Dupixent sBLA accepted for FDA review for the …
3 days ago · Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive ...
Dupixent approved in the US as the first-ever biologic medicine …
Sep 27, 2024 · Dupixent has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory related diseases such as asthma and atopic dermatitis.
Dupixent® (dupilumab) Is the First and Only Biologic to Achieve ...
Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease. If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union .
Dupixent® (dupilumab) Phase 3 Trial Confirms Significant …
Sep 11, 2024 · Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores from baseline.
Dupixent® late-breaking data from NOTUS confirmatory phase 3 …
May 20, 2024 · NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease …
FDA, after delay, clears Regeneron and Sanofi drug for COPD
Sep 27, 2024 · Dupixent is now cleared for use as an add-on maintenance treatment for adults with a certain kind of chronic obstructive pulmonary disease, or COPD, that can’t be controlled with other medications. The decision makes Dupixent the first biologic medicine approved in the U.S. for COPD, a lung disease that makes it difficult to breathe and is ...
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
3 days ago · Regeneron and Sanofi announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and pediatric patients ...