First new asthma treatment in a decade

There is new hope for those with “difficult to treat” asthma in the new year, with breakthrough biologic to be PBS listed on 1 Jan

Nucala (mepolizumab) is the first therapy to be approved as an add-on treatment for with severe refractory eosinophilic asthma.

Similar to Novartis’ Xolair (omalizumab), GSK’s Nucala (mepolizumab) is designed to target specific pathways of inflammation that do not respond to usual steroid treatment, and medical practitioners hope it will help reduce overuse of steroids in the long term.

Asthma researcher and Professor of Immunology and Allergy at Western Sydney University and Campbelltown Hospital, Professor Connie Katelaris, says the new therapy is a significant development for this difficult-to-treat group.

“This is the first new treatment for asthma in a decade, and only the second of its kind,” Prof Katelaris said at a GSK media event.

“Not all asthma is the same and we may need different approaches to different types of asthma. Some people do well with corticosteroids or bronchodilators, others are in and out of hospital or die from asthma.”

People with severe eosinophilic asthma are characterised by a high number of emergency department admissions, high costs and poor asthma control, she says.

“Most of these [people] are on excessive amounts of steroids,” says Prof Katelaris, adding that a lot of the comorbidities they may have are a direct consequence of the long-term steroid use, such as osteoporosis and Type 2 diabetes.

And, despite steroid treatment, this group still experience persistence of eosinophils and exacerbations.

One randomised controlled trial of mepolizumab, which was published in the New England Journal of Medicine and funded by GSK, showed a 53% reduction in clinically significant exacerbations and a 61% reduction in exacerbations requiring hospitalisation or emergency department admission.

Other studies and trials conducted since 2012 have also received positive results.

At more than $1000 a month, the therapy is expensive but still costs “less than eight hospital admissions a year,” Prof Katelaris points out.

“You need to have this all the time so it’s very high cost. The government needs to know the right medications to invest in. It requires reliable identification of the target patient population.”

Identification of people with this type of inflammation will be through biomarkers that reveal eosinophil levels in the patient.

Nucala is designed to be delivered via subcutaneous injection every four weeks by a healthcare professional, with the hope that patients will be able to self-administer in the future.

Regarding the drug’s safety, Prof Katelaris says it does not present many problems because “it’s very clean, very targeted”.

“This is a drug with an excellent safety profile,” she says.

The Nucala listing is expected to benefit more than 370 patients, who would otherwise pay more than $21,000 annually.

In addition to Nucala, Spiriva Respimat will also be PBS listed next year from 1 February 2017. According to Health Minister Sussan Ley, patients currently pay more than $700 per year for the medicine.

Professor Connie Katelaris has served on advisory boards and been involved in clinical trials sponsored by GSK for which compensation was received. In relation to the media announcement on Nucala, GSK states that no compensation was provided to Professor Katelaris and opinions expressed are her own.

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1 Comment

  1. Drugby

    Xolair (omalizumab) is indicated for severe allergic asthma, with raised IgE levels and positive skin prick test or RAST; whereas Nucala (mepolizumab) is add-on treatment for patients aged 12 years and over the severe refractory eosinophilic asthma (high blood or sputum eosinophils). They are two distinct phenotypes, although some patients may have both phenotypes. Mepolizumab is an anti-IL-5 mab and omalizumab is a humanised antibody to immunoglobulin E.

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