RESEARCH pharmaceutical giant GlaxoSmithKline (GSK) has flagged a possible Pharmaceutical Benefits Scheme (PBS) listing of its new therapy for severe refractory eosinophilic asthma early in 2017.
Nucala (mepolizumab) will be the first targeted anti-interleukin-5 (anti-IL-5) therapy to be approved as an add-on treatment for severe refractory eosinophilic asthma.
Patients with severe eosinophilic asthma have increased eosinophil levels measurable in the blood and airways, and they have an increased risk of severe exacerbations.
Between 5-10% of asthma sufferers have this more severe form of the disease, amounting to as many as 240,000 Australians for whom managing their day-to-day symptoms is an ongoing struggle.
Asthma researcher and Professor of Immunology and Allergy at Western Sydney University and Campbelltown Hospital, Professor Connie Katelaris, said she welcomes the availability of new treatments for Australia's severe asthmatic population on the PBS, particularly those designed for patients who weren't responding to existing treatments.
Eosinophilic disease can manifest in many ways, being an abnormality of the immune system, and Nucala is a humanised monoclonal antibody targeted against human IL-5, inhibiting IL-5 signalling, thereby reducing the production and survival of eosinophils.
Nucala will be physician-administered as a subcutaneous injection once per month until the patient is deemed fit to self-administer, Katelaris explained.
Apart from local skin effects from the injection, the side effect profile is not unlike that of placebo, she added.
It is anticipated that the product will be prescribed by specialists in hospitals, while pharmacists, also initially only in hospitals, will be provided with patient support materials but ultimately community pharmacies will also receive counselling materials, GSK said.
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