Genentech’s Xolair gets US paediatric use
Genentech’s Xolair (omalizumab) has been approved in the US for moderate to severe persistent asthma in children.
The Roche unit said the label extension applies to children aged six to 11 years of age, who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids.
In the US, Genentech and Roche’s Swiss rival, Novartis, work together to develop and co-promote Xolair.
Xolair is already approved to treat people 12 years and older with allergic asthma.
The latest approval is supported by multi-centre, randomised, double-blind, placebo-controlled phase 3 studies that assessed the efficacy and safety of Xolair in children from six to 11 years old with moderate to severe persistent uncontrolled allergic asthma.
The primary study was a 52-week trial, with the primary endpoint measured at 24 weeks.
Supportive safety and efficacy data come 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 12 years and older.
Xolair was first approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids.
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