FDA accepts supplemental biologics license application for Xolair for the treatment of nasal polyps.- Genentech/Roche

Genentech, a member of the Roche Group announced that the FDA has accepted the company�s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE). The FDA is expected to make a decision on approval for this indication by Q3 2020

Nasal polyps is a common and potentially debilitating condition in adults, impacting 13 million people in the U.S. Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids, which often cannot effectively control symptoms over time due to nasal polyps regrowth. Nasal polyps presents as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow. Frequently co-occurring with other respiratory conditions, nasal polyps impacts approximately 45% of people with adult-onset asthma and approximately 30% of people with chronic rhinosinusitis, resulting in chronic rhinosinusitis with nasal polyps (CRSwNP) if the nasal polyps and sinusitis symptoms are present for 12 weeks or longer. After sinus surgery, nasal polyps recurs in up to 80% of people, with approximately 40% requiring at least one further surgery.

This sBLA is based on results from the Phase III POLYP 1 and POLYP 2 trials, which showed Xolair met both co-primary and multiple secondary endpoints in treating adult patients with CRSwNP who have not adequately responded to intranasal corticosteroids. The co-primary endpoints were change from baseline in Nasal Polyp Score (NPS) and change from baseline in average daily Nasal Congestion Score (NCS) at 24 weeks. Key secondary endpoints that were met included improvement in the Sino-Nasal Outcome Test-22 (SNOT-22) health-related quality of life assessment, improvement in sense of smell, post-nasal drip (posterior rhinorrhea), and runny nose (anterior rhinorrhea). The safety profile in these trials were consistent with the known safety profile for Xolair, with no new unexpected safety signals identified. Full results from the POLYP 1 and POLYP 2 studies were recently presented during an oral session at the 2019 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting (abstract #D450).