Rhinitis/rhinorrhea (Intranasal Products) Archives - MPR

Rhinitis/rhinorrhea (Intranasal Products)

FDA to Review Omalizumab for Chronic Rhinosinusitis With Nasal Polyps

The Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for omalizumab (Genentech) for the treatment of adults with chronic rhinosinusitis with nasal polyps who have had an inadequate response to intranasal corticosteroids. The sBLA includes data from the POLYP 1 and POLYP 2 trials, which showed that treatment…

Dupixent sBLA Gets Priority Review for Chronic Rhinosinusitis With Nasal Polyps Indication

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…