GlaxoSmithKline (GSK) has secured FDA approval for Nucala (mepolizumab) for the treatment of adult and paediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES).
The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US.
HES is a complex, life-threatening condition that impacts nearly 5,000 patients in the US. Today’s approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases,” said Dr Hal Barron, Chief Scientific Officer and President R&D of GSK.
The approval follows a priority review of data from a clinical development programme that included positive results from a pivotal phase 3 study, recently published in the Journal of Allergy and Clinical Immunology.
The study showed 50% fewer patients experienced a HES flare (worsening of symptoms or eosinophil threshold requiring an escalation in therapy) when treated with Nucala, compared to placebo, when added to standard of care treatment over the 32-week study period (28% vs 56%).
Nucala is currently used as an add-on maintenance therapy for severe eosinophilic asthma and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), and is being investigated in several other eosinophil-driven diseases.
