Genentech announced positive topline data from two phase 3 trials, POLYP 1 and POLYP 2, evaluating Xolair (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids.
In the POLYP 1 (N=138) and POLYP 2 (N=127) phase 3 trials patients were randomized to receive either Xolair or placebo by subcutaneous injection every 2-4 weeks. The co-primary endpoints for both trials were change from baseline in average daily Nasal Congestion Score (NCS) at week 24, and change from baseline in Nasal Polyp Score (NPS) to week 24.
Results demonstrated statistically significant and clinically relevant improvements in both of the co-primary endpoints. Key secondary endpoints were also met, including improvement in smell, post-nasal drip (posterior rhinorrhea score), runny nose (anterior rhinorrhea score) and the Sino-Nasal Outcome Test-22 (SNOT-22) health-related quality of life assessment. Additional data from these trials will be presented at an upcoming scientific congress.
“The results from these pivotal studies provided further support that IgE plays a role in inflammatory and respiratory conditions, and showed that Xolair reduced the size of nasal polyps and associated symptoms that impact these patients’ quality of life,” said Sandra Horning, MD, CMO and head of Global Product Development. “We plan to discuss these results with the FDA with the goal of bringing this new treatment option as soon as possible to people who do not experience relief with the current standard of care.”
Xolair, an injectable immunoglobulin E (IgE) blocker, is currently indicated for the treatment of moderate-to-severe persistent asthma in patients ≥6yrs of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids. In addition, Xolair is indicated to treat chronic idiopathic urticaria in symptomatic patients 12 years of age and older despite H1-antihistamine treatment.
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