sBLA filed with FDA for Xolair (omalizumab) in allergic asthma for paediatric patients- Genentech/Roche

The FDA has accepted for review the company’s supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab), from Genentech/Roche, in allergic asthma to paediatric patients. The FDA will review Xolair in children from six through 11 years for the treatment of moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Genentech anticipates hearing from the FDA later this year.

The sBLA is supported by multi-center, randomised, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children aged six to 11 years with moderate to severe persistent uncontrolled allergic asthma. The primary study is a 52-week trial, with the primary endpoint measured at 24 weeks. Supportive safety and efficacy data comes from a 28-week study. Additional safety data come from a five-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients years and older.

Comment: Omalizumab is already indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma in children aged 6–12 in the EU, marketed by Novartis as Xolair.