Xolair omalizumab regulatory update
The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Xolair omalizumab from Novartis as an add-on to optimized standard therapy for a subgroup of patients ages >=6 years with severe, persistent allergic asthma. Xolair is recommended for asthma patients who need continuous or frequent treatment with oral corticosteroids, defined as >=4 courses in a year. The recommendation, which is contingent on Novartis providing the drug at an undisclosed discount under a patient access scheme, reverses the committee's previous recommendations against the use of Xolair in all asthma patients - NICE recommended against the use of Xolair in adults in November and against the use of Xolair in children ages >=6 years in August 2010 (see BioCentury, Aug. 16, 2010 & Nov. 12, 2012). ...