GSK, generic makers win TGA nod

The TGA has approved GSK’s Exdensur, two generics of PBS listed medicines, and a handful of over-the-counter medicines.

Exdensur is indicated as add-on maintenance treatment of severe asthma in patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium-to-high-dose inhaled corticosteroids plus another asthma controller.

Additionally, the injectable IL-5 inhibitor is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with chronic rhinosinusitis with nasal polyps inadequately controlled by systemic corticosteroids or surgery.