Xolair omalizumab regulatory update
The U.K.'s NICE issued a final appraisal determination (FAD) recommending against the use of Xolair omalizumab from Novartis to treat severe persistent asthma in children aged six to 11 years. The FAD reiterates a preliminary appraisal issued in June. The recombinant humanized mAb against IgE is approved as add-on therapy to improve asthma control in patients with severe persistent allergic asthma in patients 6 and older.
NICE said it had received comments that not recommending Xolair in this age group is unfair because NICE recommends the drug under specific circumstances for children 12 and older. NICE, which said it would be preferable to develop a single guidance covering all age groups, recommended a review of the recommendations for all age groups. NICE said that if referred by the Department of Health, the review would need to go through the agency's normal technology appraisal process. ...