FDA News

FDA expands use of Xolair for allergic asthma in younger children

Genentech announced the FDA approved an expansion of the drug label for Xolair for the treatment of moderate to severe persistent asthma in patients aged 6 to 11 years, who have had a positive skin test or in vitro reactivity to an airborne allergen with symptoms that are ineffectively controlled with inhaled corticosteroids.

Xolair (omalizumab) was previously approved to treat patients aged 12 years and older with allergic asthma, but is not indicated for the treatment of other allergic conditions, acute bronchospasm or status asthmaticus.

Sandra Horning, MD

Sandra Horning

“Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and older.”

The FDA based its approval on 52-week data from a phase 3 multicenter, randomized, double blind safety and efficacy study of Xolair as an add-on therapy in children aged six to 11 years with allergic asthma that was inadequately controlled, despite use of inhaled corticosteroids with or without the use of other controller asthma medications.

Study results demonstrated that patients treated with Xolair experienced a statistically significant lower rate of asthma exacerbations (0.45) vs. patients receiving placebo (0.64), representing a 31% relative rate reduction (RR= 0.69, 95% CI, 0.53, 0.90).

“Uncontrolled allergic asthma can significantly affect the lives of children,” Cary Sennett, MD, PhD, president and chief executive officer of the Asthma and Allergy Foundation of America, said in the release. “This approval helps to address an important unmet need for children older than six and their parents or caregivers.”

The most common adverse events associated with the use of Xolair among children included nasopharyngitis, pyrexia, streptococcal pharyngitis, otitis media, viral gastroenteritis, and epistaxis.

Genentech announced the FDA approved an expansion of the drug label for Xolair for the treatment of moderate to severe persistent asthma in patients aged 6 to 11 years, who have had a positive skin test or in vitro reactivity to an airborne allergen with symptoms that are ineffectively controlled with inhaled corticosteroids.

Xolair (omalizumab) was previously approved to treat patients aged 12 years and older with allergic asthma, but is not indicated for the treatment of other allergic conditions, acute bronchospasm or status asthmaticus.

Sandra Horning, MD

Sandra Horning

“Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and older.”

The FDA based its approval on 52-week data from a phase 3 multicenter, randomized, double blind safety and efficacy study of Xolair as an add-on therapy in children aged six to 11 years with allergic asthma that was inadequately controlled, despite use of inhaled corticosteroids with or without the use of other controller asthma medications.

Study results demonstrated that patients treated with Xolair experienced a statistically significant lower rate of asthma exacerbations (0.45) vs. patients receiving placebo (0.64), representing a 31% relative rate reduction (RR= 0.69, 95% CI, 0.53, 0.90).

“Uncontrolled allergic asthma can significantly affect the lives of children,” Cary Sennett, MD, PhD, president and chief executive officer of the Asthma and Allergy Foundation of America, said in the release. “This approval helps to address an important unmet need for children older than six and their parents or caregivers.”

The most common adverse events associated with the use of Xolair among children included nasopharyngitis, pyrexia, streptococcal pharyngitis, otitis media, viral gastroenteritis, and epistaxis.