The subjects were randomized to subcutaneous omalizumab
at 300 mg every 4 weeks or placebo for 28 weeks; they were then further assessed for changes in quality of life during 8 weeks off omalizumab
Methods: Consecutive patients with severe asthma disease (n=15; Group IA, pretreatment and Group IB, post-treatment) underwent omalizumab
The latest EAACI/GA2LEN/EDF and WAO guidelines recommend the use of omalizumab
in the management of refractory CSU.
Benefits of omalizumab
as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE.
The EU approval of omalizumab
in CSU is truly exciting for patients with this chronic and debilitating skin disease," said David Epstein, Division Head of Novartis Pharmaceuticals.
was first approved in 2003 for moderate to severe asthma.
Each was randomly assigned to take one of three dosing regimens of omalizumab
, or placebo, after which they were monitored through regular checkups for four months.
works by blocking an antibody that triggers asthma responses such as wheezing and shortness of breath.
The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-4 that the safety and efficacy data on omalizumab
did not provide "substantial and convincing evidence" to support approval for the proposed indication: the treatment of asthma in patients aged 6-11 years with moderate to severe persistent asthma whose symptoms are inadequately controlled with inhaled corticosteroids (ICS) and who have a positive skin test result or in vitro reactivity to a perennial aeroallergen.
has been deemed appropriate for patients who have allergic asthma, and for those who have severe persistent asthma that is difficult to control with the combination of high-dose ICS and LABA.
GENEVA -- In real-world clinical practice, roughly two-thirds of patients with chronic spontaneous urticaria treated with the approved dose of omalizumab
will achieve good disease control--and for those who don't, three-quarters will respond upon updosing to 450 or 600 mg every 4 weeks.