The Therapeutic Goods Administration (TGA) has approved Nucala (mepolizumab) as an add-on treatment in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids.
Nucala is the first directly targeted anti-IL-5 therapy approved for patients with severe chronic rhinosinusitis with nasal-polyps (CRSwNP).
Professor Richard Harvey, a leading Otolaryngology Head and Neck Surgeon and researcher, says this latest approval will help to reduce the burden of CRSwNP for patients who experience chronic inflammation despite maximal treatment.
“Depending on their presenting symptoms, patients with nasal polyps often see a variety of specialists including allergists, immunologists and ENT specialists in addition to receiving primary care from their GP. The symptoms of CRSwNP can have a profound effect on a patient’s quality of life – from mental wellbeing, reduced productivity, nasal obstruction and loss of smell.
“Until now, we’ve had very limited tools to treat patients who continue to have persistent symptoms following treatment. New biologic treatment options, like Nucala, allow us to target the underlying eosinophilic inflammation, reducing reliance on corticosteroid medication, and provide this group of patients with relief from severe symptoms.”
Dr Andrew Gillman, specialist respiratory physician and lead investigator on SYNAPSE, says this latest approval is an important milestone for Australians suffering from the debilitating effects of CRSwNP.
“This is welcome news for healthcare professionals treating patients with CRSwNP, especially given the experience many respiratory physicians have had using Nucala in patients with severe eosinophilic asthma. Patients with CRSwNP often have coexisting severe asthma, so biological treatments can play an important role in managing upper and lower airway diseases,” says Dr Gillman.
“Nucala has demonstrated improvements in patient quality of life across nasal symptoms, ear/face symptoms, fatigue, impact on sleep and emotional impact. This means that in addition to targeting the underlying eosinophilic inflammation associated with recurrent nasal polyps, treatment is also helping improve quality of life for patients.”
Dr Alan Paul, Medical Director at GSK Australia, says the company was proud to help bring this innovation to patients.
“Australians living with chronic rhinosinusitis with nasal polyps experience many unpleasant symptoms that significantly impact their quality of life. This approval provides appropriate patients with the first anti-IL-5 treatment option to help reduce both the chronic nasal symptoms and the burden of disease,” says Dr Paul.
“This approval highlights the critical role of the Australian medical research community and local trials in helping deliver innovative medicines to patients. GSK is committed to ongoing research into the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet patient needs and today’s announcement is evidence of that.”
In support of patient access, GSK is working with stakeholders to obtain a PBS listing for Nucala for CRSwNP.
