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UK's NICE Rejects Novartis AG's Xolair for Children

6/1/2010 6:47:25 AM

FRIMLEY, England, June 1, 2010 /PRNewswire/ --

- Just for UK media, not for Ireland

- This release is intended for consumer media

- Add-On Omalizumab Reduces the Rate of Asthma Attacks in Children Aged 6 to 11 Years With Severe Persistent Allergic Asthma Whose Symptoms Remain Uncontrolled Despite Best Available Current Therapies[2]

- Today's Decision Made Despite Pivotal Study Showing Omalizumab Halves Asthma Attacks at One Year With a Good Overall Safety and Tolerability Profile in Children Aged 6 to 11 Years [3,4]

Novartis is disappointed that the National Institute for Health and Clinical Excellence (NICE) has decided against recommending omalizumab for children aged 6 to 11 years with severe, persistent allergic asthma in England and Wales because it does not consider it to be a cost-effective use of NHS resources1. Omalizumab is the first in a generation of drugs for severe, difficult-to-control allergic asthma, where patients have an oversensitive immune system, and is already recommended by NICE for use in patients aged 12 years and older[5].

Last month the Scottish Medicines Consortium (SMC) accepted the use of omalizumab for children in Scotland aged 6 to 11 years with severe, persistent allergic asthma who are prescribed chronic systemic steroids[6].

Asthma is a chronic, inflammatory lung disease which affects approximately 1.1 million children in the UK[7]. Of the 80,000 hospital admissions for asthma in the UK every year, 41% are for children under 14 years[8]. Within this group of paediatric patients, there are a small but significant number of children with severe symptoms in whom asthma control remains poor despite best available therapy. These children are currently treated with frequent or maintenance doses of oral corticosteroids (OCS) together with other controller medications. As such, they are at risk of serious OCS-related side-effects, including growth retardation, osteoporotic fractures, diabetes and cardiovascular events such as hypertension and heart failure[9]. It is estimated that just over 300 of these children may be eligible for treatment with omalizumab[10].

Dr Tim Cave, Medical Director, Novartis UK said: "We are disappointed by NICE's initial decision and concerned that the small number of young children with severe asthma in whom omalizumab would be used will be denied access to this drug. If the initial decision stands, doctors will not be able to give children a treatment which could alleviate their asthma symptoms."

Results from a pivotal study submitted to NICE showed that omalizumab reduced asthma attacks by a third after 24 weeks of treatment[2] and provided an overall reduction of 50% at one year[2].

Omalizumab is the only licensed medicine shown to stabilise severe allergic asthma in a significant proportion of patients by blocking the action of the IgE antibody, a factor in the inflammatory cascade associated with allergic asthma[2]. Omalizumab thereby inhibits the body's reaction to inhaled particles such as cat dander and house-dust mite droppings that cause the symptoms associated with severe allergic asthma[3,4]. By targeting IgE, omalizumab can prevent the onset of debilitating symptoms, such as shortness of breath and wheezing, in severely affected patients.

Omalizumab was approved as add-on therapy in the EU by the European regulator (EMEA) in 2005 for patients 12 years and older with severe persistent allergic asthma. More recently omalizumab was approved by the same regulator as add-on therapy for severe persistent allergic asthma in children aged 6 to 11 years[3].

NICE has invited Novartis and other consultees/commentators in the appraisal process, including patient/carer groups, to comment on the ACD by 5pm on 22nd June. It is also possible for members of the public to comment via the NICE website.

Omalizumab was developed under an agreement between Novartis Pharma AG, Genetech, Inc., and Tanox, Inc. and launched in the UK in 2005.

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