Genentech recently announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) for the treatment of persistent allergic asthma in children aged 6 to 11 years old. Xolair therapy was already approved for children aged 12 years-old or older.
The new approval is indicated for the treatment of children who have had a positive skin test or laboratory test reactivity to an airborne allergen, and suffer from symptoms that are not sufficiently controlled with inhaled corticosteroids.
“Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children,” said Dr. Sandra Horning, chief medical officer and head of Global Product and Development at Genentech, 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.”
Xolair is an injectable prescription medicine recommended to treat moderate-to-severe allergic asthma in patients whose symptoms are not controlled by corticosteroids – a skin/blood test can be performed to see if a patient suffers from all year-round allergies.
The drug was first approved in 2003. Since then, more than 200,000 patients have been treated with Xolair. The recent approval was supported by results from multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical studies. The trials evaluated the efficacy and safety of the drug candidate in children aged 6 to 11 years with moderate-to-severe persistent uncontrolled allergic asthma.
The lead trial lasted 52 weeks, with its primary endpoint being the rate of asthma flareups during the first 24 weeks. Steroid doses were sustained from baseline; after 24 weeks, participants were followed for an additional 28-week period during which inhaled corticosteroid adjustment could be made.
At the end of the first period, the group under Xolair treatment had a statistically significantly lower asthma exacerbations rate, when compared to the placebo group (0.45 versus 0.64, respectively) – Xolair induced a 31 percent relative rate reduction in exacerbations rate. During the whole 52 weeks, the rates varied (0.78 versus 1.36, respectively) – the candidate achieved a 43 percent relative rate reduction.
A supporting trial, lasting 28 weeks, provided additional safety and efficacy data on Xolair, which was later complemented with a second five-year, non-randomized, observational, post-marketing study to evaluate the long-term safety of the drug in patients older than 12 years.
The most common side effects reported included common cold symptoms, headaches, fever, upper abdominal pain, sore throat, ear discomfort, intestinal infection causing abdominal pain, nausea and vomiting, insect bites and nose bleeds.
“Uncontrolled allergic asthma can significantly affect the lives of children,” said Dr. Cary Sennett, the Asthma and Allergy Foundation of America (AAFA)’s President and chief executive officer. “This approval helps to address an important unmet need for children older than six and their parents or caregivers.”
Asthma is one of the most common pediatric diseases, affecting nearly 6.3 million people under the age of 18 years in the United States. In adults, the number reaches about 24 million. Of these people, nearly 60 percent suffer from allergic asthma. About 70-80 percent of school-aged children with the condition also have other allergies that trigger asthma.